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CARDIOVASCULAR
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IMPORTANT PRODUCT INFORMATION

We pursue excellence in every product we make. We have a strong history of product safety and reliability, and we remain dedicated to developing technology and products that save and improve the lives of patients worldwide.

We take our responsibilities as a leading device manufacturer very seriously and recognize our primary responsibility is to ensure that our devices are of the highest quality and function safely and properly.

Our commitment to business integrity means we quickly share with professionals and patients the important information they need about our products’ performance and safety. These product advisories and communications remain available for review.

Urgent Field Safety Notice: Merlin Patient Care System (PCS) Communication - May 12, 2020

We provided an Urgent Field Safety Notice to customers communicating that Merlin™ PCS V25.0.2 rev 3 programmer software contains an anomaly causing ventricular automatic capture threshold trending configuration values to not properly be communicated and stored in the Gallant™ family of high-voltage devices including ICDs and CRT-Ds. When this occurs, reported automatic capture thresholds may be falsely elevated, however, the algorithm functions to provide pacing outputs that will always be greater than the reported automatic capture threshold in order to ensure capture. Please find the communication below for further information.

Physician Communication - Merlin Patient Care System (PCS) Software Version 25.0.2 Rev 3

Important Medical Device Correction: Ellipse Implantable Cardioverter Defibrillator (ICD) RF Communication – January 22, 2020

We provided an Important Medical Device Correction notice to customers communicating that a small number of Ellipse™ devices may lose wireless radiofrequency (RF) communication following a recent device software update. Please find the below communication document for further information.

Physician Communication - For a Subset of Ellipse Implantable Cardioverter Defibrillators

Important Medical Device Recall: HeartMate 3 Modular Cables with LVAS Controller Important Information – December 20, 2019

We provided an Important Medical Device Advisory notice to customers regarding incorrect insertion of the HeartMate 3™ modular cable into the HeartMate 3 Left Ventricular Assist System controller. Please find the below physician communication document for further information.

Physician Communication - HeartMate 3 Modular Cables (Catalog #106525INT) when used with Left Ventricular Assist System (Catalog #106524INT)

Urgent Medical Device Recall: HeartMate Mobile Power Unit with HeartMate 3 LVAS Important Information – December 2, 2019

We provided an Urgent Medical Device Recall notice to customers regarding inference of static electricity with the HeartMate Mobile Power Unit™ when used with HeartMate 3 Left Ventricular Assist System. Please find the below physician communication document for further information.

Physician Communication - HeartMate Mobile Power Unit (Catalog #107754) when used with HeartMate 3 Left Ventricular Assist System (Catalog #106524US)

Important Field Safety Notice: CentriMag Acute Circulatory Support System Important Information Line Communication - August 22, 2019

We provided an Important Field Safety Notice to customers communicating that we have received reports of CentriMag™ Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI). Please find the below physician communication document for further information.

Physician Communication - CentriMag Acute Circulatory Support System Motor (Model 201-10002)

Field Safety Notice: Ellipse Implantable Cardioverter Defibrillator (ICD) – Latent Electronics Vulnerability - June 20, 2019

We initiated a Field Safety Corrective Action and subsequently provided an Field Safety Notice to customers. This notice communicated patient management recommendations for a small number of Ellipse implantable cardioverter defibrillators which may be subject to a latent vulnerability in the electronics circuitry. Please find the below physician communication document for further information.

Physician Communication - Ellipse Implantable Cardioverter Defibrillators (Models CD2377-36QC, CD2377-36C, CD1377-36QC, CD1377-36C)


Product Advisory Archive

Important Field Safety Notice: CentriMag Acute Circulatory Support System Important Information – September 5, 2018

We provided an Important Field Safety Notice to customers communicating that we have received reports where damage to the cable that connects the motor to the console resulted in interruption of active support. This communication is to remind our physician and hospital partners of the importance of following the proper method for exchanging the CentriMag Acute Circulatory Support System Motor (Model# 201-10002) in the event the system experiences an interruption of power.

Physician Communication - CentriMag Acute Circulatory Support System Motor (Model# 201-10002)

Physician Communication - CentriMag Acute Circulatory Support System Corrective Action FAQ

Urgent Medical Device Recall: CardioMEMS Hospital and Patient Electronics System Important Information – June 14, 2018

Abbott provided an Urgent Medical Device Recall notice to hospitals, clinics and patients communicating that a small number of CardioMEMS™ Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a false Error 5 message due to an incorrectly configured component within the device electronics. Please find the below patient and hospital communication documents for further information.

Hospital Letter - CardioMEMS Hospital and Patient Electronics System Error 5 (Model #CM3000 Hospital Electronics System, #CM1100 Patient Electronics System)

Important Medical Device Advisory: HeartMate 3 Left Ventricular Assist System Important Information – May 28, 2018

On May 28, 2018, we provided an update to the Important Medical Device Advisory to physicians regarding the HeartMate 3 (HM3) Left Ventricular Assist System in which certain patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm.

Physician Communication - HeartMate 3 Left Ventricular Assist System Outflow Graft Twist Occlusion (Catalog #10652INT HM3 LVAS Kit)

 

On April 5, 2018, we provided an Important Medical Device Advisory to physicians regarding the HeartMate 3 Left Ventricular Assist System in which certain patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm.

Physician Communication - HeartMate 3 Left Ventricular Assist System Outflow Graft Twist Occlusion

Medical Device Advisory: Implantable Cardioverter Defibrillator Cybersecurity Firmware Update – April 23, 2018

We recently notified physicians about the availability of new device firmware to further strengthen the security and improve the performance of our high voltage (HV) implantable cardiac devices (ICDs and CRT-Ds). The firmware upgrade includes improved cybersecurity protection and an update to provide device based premature battery depletion detection in certain HV devices.

International English - Physician Communication - Battery Performance Alert and Cybersecurity Firmware Upgrade for Certain ICD & CRT-D Devices

Patient Communication

We have developed online information for patients, located here. The page includes important information about the update and responses to frequently asked questions from patients.

Medical Device Advisory: Premature Battery Depletion with Implantable Cardioverter Defibrillator - April 23, 2018

We recently notified physicians about the availability of new device firmware to further strengthen the security and improve the performance of our high voltage (HV) implantable cardiac devices (ICDs and CRT-Ds).


As communicated in August 2017, the BPA algorithm is a management tool and is intended to provide earlier notification of abnormal battery performance for Battery Advisory Devices prior to premature battery depletion. Until now, detection of this alert has only been available through the Merlin.net™ remote monitoring system and the Merlin programmer during routine follow-up evaluations. This firmware upgrade now allows for device-based detection of abnormal battery performance and if BPA is triggered, a vibratory notification is delivered to the patient, thereby ensuring continuous monitoring in situations where adherence to transmission schedules is challenging (e.g. travel). Additionally, an alert will still continue to be provided to physicians through the Merlin.net remote monitoring system and the Merlin programmer during subsequent follow-up.

International English - Physician Communication - Battery Performance Alert and Cybersecurity Firmware Upgrade for Certain ICD & CRT-D Devices

International English - Physician Communication - Battery Performance Alert White Paper

August 29, 2017 – As part of our commitment to continuous improvement, we have recently released an update intended to provide physicians with earlier warning of the potential for premature battery depletion due to short circuits from lithium clusters in patients’ implantable defibrillators.

The new Battery Performance Alert, which can be used as a patient management tool and is intended to help identify potential premature battery depletion in the following devices subject to the October 11, 2016 Medical Device Advisory: Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™, and Unify Quadra™.

International English - Physician Communication - Battery Performance Alert Update Field Safety Notice

France - Physician Communication - Battery Performance Alert Update Field Safety Notice

Germany - Physician Communication - Battery Performance Alert Update Field Safety Notice

Italy - Physician Communication - Battery Performance Alert Update Field Safety Notice

Portugal - Physician Communication - Battery Performance Alert Update Field Safety Notice

Spain - Physician Communication - Battery Performance Alert Update Field Safety Notice

Physician Communication - Battery Performance Alert White Paper

On October 10, 2016, St. Jude Medical provided an Important Medical Device Advisory to physicians regarding the St. Jude Medical ICD and CRT-D devices manufactured before May 23, 2015 for models Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra:

Physician Communication, July 2018 - ICD Premature Battery Depletion Advisory Update

Physician Communication - Premature Battery Depletion with Implantable Cardioverter Defibrillator

Physician Communication - Programmed Parameters for ERI Example

Physician Communication - Estimated Performance of Affected ICD and CRT-D Devices

Canada-English – Physician Communication - Premature Battery Depletion with Implantable Cardioverter Defibrillator

Canada-French – Physician Communication - Premature Battery Depletion with Implantable Cardioverter Defibrillator

Croatia – Physician Communication - Premature Battery Depletion with Implantable Cardioverter Defibrillator

Czech Republic – Physician Communication - Premature Battery Depletion with Implantable Cardioverter Defibrillator

Hungary – Physician Communication - Premature Battery Depletion with Implantable Cardioverter Defibrillator

Japan – Physician Communication - Premature Battery Depletion with Implantable Cardioverter Defibrillator

Netherlands – Physician Communication - Premature Battery Depletion with Implantable Cardioverter Defibrillator

Portugal – Physician Communication - Premature Battery Depletion with Implantable Cardioverter Defibrillator

Romania – Physician Communication - Premature Battery Depletion with Implantable Cardioverter Defibrillator

Russia – Physician Communication - Premature Battery Depletion with Implantable Cardioverter Defibrillator

Serbia – Physician Communication - Premature Battery Depletion with Implantable Cardioverter Defibrillator

Slovakia – Physician Communication - Premature Battery Depletion with Implantable Cardioverter Defibrillator

Slovania – Physician Communication - Premature Battery Depletion with Implantable Cardioverter Defibrillator

Spain – Physician Communication - Premature Battery Depletion with Implantable Cardioverter Defibrillator

Turkey – Physician Communication - Premature Battery Depletion with Implantable Cardioverter Defibrillator

Australia – Physician Communication - Premature Battery Depletion with Implantable Cardioverter Defibrillator

Germany – Physician Communication - Premature Battery Depletion with Implantable Cardioverter Defibrillator

New Zealand – Physician Communication - Premature Battery Depletion with Implantable Cardioverter Defibrillator

Patient Communication

April 16, 2018 Update – Abbott has developed online information for patients, located here. The page includes important information about the new Battery Performance Alert update and responses to frequently asked questions. Patients can also look up their serial numbers for their devices and learn more about remote monitoring options.

Urgent Field Safety Notice: Nanostim Leadless Cardiac Pacemaker Field Safety Notice – April 5, 2018

We provided an update regarding the investigation of the Nanostim™ Leadless Cardiac Pacemaker (LCP) detached docking button.

Physician Communication - Urgent Field Safety Notice Docking Button Detachment in Nanostim Leadless Cardiac Pacemaker

On November 17, 2017, Abbott provided an Urgent Field Safety Notice to physicians regarding the Nanostim Leadless Cardiac Pacemaker.

Physician Communication - Docking Button Detachment in Nanostim Leadless Cardiac Pacemaker

Pacemaker Cybersecurity Firmware Update – August 29, 2017

We provided an update to physicians with information on a pacemaker firmware update for Abbott pacemaker models which include the RF telemetry versions of the following devices Outside of the U.S.: Accent SR RF™, Accent ST™, Accent MRI™, Accent ST MRI™, Assurity™, Assurity +™, Assurity MRI™, Accent DR RF™, Anthem RF™, Allure RF™, Allure Quadra RF™, Quadra Allure MP RF™, Quadra Allure™, and Quadra Allure MP™.

International English - Physician Communication - Pacemaker Firmware Update Field Safety Notice

France - Physician Communication - Pacemaker Firmware Update Field Safety Notice

Germany - Physician Communication - Pacemaker Firmware Update Field Safety Notice

Italy - Physician Communication - Pacemaker Firmware Update Field Safety Notice

Japan - Physician Communication - Pacemaker Firmware Update Field Safety Notice

Portugal - Physician Communication - Pacemaker Firmware Update Field Safety Notice

Spain - Physician Communication - Pacemaker Firmware Update Field Safety Notice

Patient Communication

Abbott has developed online information for patients, located here. The page includes important information about the update and responses to frequently asked questions from patients.

Medical Device Advisory: Nanostim Leadless Cardiac Pacemaker Important Information – October 28, 2016

We provided an Important Medical Device Advisory to physicians regarding the Nanostim Leadless Cardiac Pacemaker:

Physician Communication - Nanostim Leadless Cardiac Pacemaker

Riata and Riata ST Silicone Defibrillation Leads Information

Find information about Riata™ and Riata ST silicone defibrillation leads.

Medical Device Advisory: Optisure Dual Coil HV Leads Important Information – November 2, 2015

On November 2, 2015, we provided an Important Medical Device Advisory to physicians regarding the Optisure™ Dual Coil HV Leads:

Canada - Physician Communication - Optisure Dual Coil HV Leads

On November 4, 2015, St. Jude Medical provided an Important Medical Device Advisory to physicians regarding the Optisure™ Dual Coil HV Leads:

International - Physician Communication - Optisure Dual Coil HV Leads

On November 5, 2015, St. Jude Medical provided an Important Medical Device Advisory to physicians regarding the Optisure™ Dual Coil HV Leads:

Japan - Physician Communication - Optisure Dual Coil HV Leads

On November 6, 2015, St. Jude Medical provided an Important Medical Device Advisory to physicians regarding the Optisure™ Dual Coil HV Leads:

Australia - Physician Communication - Optisure Dual Coil HV Leads

Medical Device Advisory: Ellipse and Ellipse ST VR/DR ICD Important Information – August 19, 2014

We provided an Important Medical Device Advisory to physicians regarding the Ellipse and Ellipse ST VR/DR Implantable Cardioverter Defibrillators (ICDs).

Physician Communication - Ellipse and Ellipse ST VR/DR ICDs

Amplatzer Septal Occluder Important Information – For Canadian Residents - April 9, 2014

Health care professional notification | Soins de santé notification professionnel

This letter is to inform physicians about important information concerning the risk of erosion associated with the Amplatzer™ Septal Occluder.

Cette lettre est d'informer les médecins sur des informations importantes concernant le risque d'érosion associé au dispositif d'occlusion septal Amplatzer™.

Health Canada Endorsed Important Safety Information on Amplatzer™ Septal Occluder (ASO)

Renseignements importants en matiere d'innocuite approuves par Sante Canada concernant Ie dispositif d'occlusion septal Amplatze

Public Notification | Avis Public

This letter is to inform the public about important information concerning the risk of erosion associated with the Amplatzer™ Septal Occluder.

Cette lettre est d'informer le public sur des informations importantes concernant le risque d'érosion associé au dispositif d'occlusion septal Amplatzer™.

Public Communication - Health Canada Endorsed Important Safety Information on Amplatzer™ Septal Occluder

Communication au public - Renseignements importants en matiere d'innocuite approuves par Sante Canada concernant Ie dispositif d'occlusion septal Amplatzer

Field Safety Notice: Accent SR and Accent DR Pacemakers Important Information – April 19, 2013

Accent™ SR Model PM1110 and Accent™ DR Model 2112 Pacemakers. Resolution of the potential for the inability to provide rate responsive sensor driven pacing rates:

Follow Up Action

St. Jude Medical Accent™ SR Model PM1110 and Accent™ DR Model 2112 Pacemakers. Potential for the inability to provide rate responsive sensor driven pacing rates:

Field Safety Notice - 7 December 2012

Field Safety Notice: Fortify ST ICDS Important Information – April 18, 2013

Information on Device Software Upgrade Procedure for Fortify™ ST ICD Models CD1235-40, CD1235-40Q, CD2235-40, CD2235-40Q:

Field Safety Notice

Medical Device Advisory: QuickSite and QuickFlex LV CRT Leads Important Information – April 4, 2012

We provided a Medical Device Advisory and Important Product Information Update to physicians regarding the QuickSite™ and QuickFlex™ LV CRT leads:

Important Product Information Update: QuickSite and QuickFlex LV CRT Leads

Physician Communication about QuickSite™ and QuickFlex™ LV CRT Leads

QuickSite and QuickFlex LV CRT Lead Update Presentation

Commitment to Quality

Abbott has a strong history of product safety and reliability, and we remain dedicated to developing technology and products that save and improve the lives of patients worldwide.

We take our responsibilities as a leading manufacturer of cardiac rhythm management devices very seriously and recognize our primary responsibility as a global medical device manufacturer is to ensure that our devices are of the highest quality and function safely and properly.

 
Product Performance

As part of our commitment to quality, we keep medical professionals and their patients informed on the performance of our devices. St. Jude Medical releases a semi-annual report detailing overall performance and reliability of its Cardiac Rhythm Management products.

Current and Archived ProductPerformance Reports

 
QuickFlex µ and Quartet Optim Insulated Leads are Not Included in this Advisory

QuickFlex™ µ and Quartet™ Optim™ insulated LV CRT leads have demonstrated superior performance during the approximately three years they have been on the market. There have been zero reports of externalized conductors in QuickFlex µ and Quartet Optim LV CRT leads, and they continue to demonstrate excellent performance by any measure.

All QuickFlex µ and Quartet Optim insulated LV CRT leads are constructed with full-body Optim™ insulation, a material shown to be 50 times more abrasion resistant than silicone insulation.1

View product information forQuickFlex µandQuartet Optim™ leads.

Epic and Atlas ICDs Important Information – January 16, 2008

Important Device Upgrade Information – Epic™ & Atlas™ Family of ICDs

We are making a programmer software upgrade available to resolve and eliminate a very rare occurrence (incidence of 8 in 143,000 devices) that could lead to a ventricular sensing anomaly in our Epic™ and Atlas™ families of Implantable Cardioverter Defibrillators (ICDs). The new programmer software (version 6.4.1 for MerlinPCS and version 6.5.1 for Model 3510) will allow a programmer to automatically identify a device that can benefit from a firmware upgrade to resolve and eliminate the potential issue with a simple, one time device software upgrade.

St. Jude Medical Field Sales Staff and Field Clinical Engineers will install this software upgrade in Merlin PCS and Model 3510 programmers in the field. Thereafter, upon initial interrogation of an Epic or Atlas family ICD, the Merlin or 3510 programmer will automatically identify implanted devices that require a firmware upgrade and will inform the clinician with a message that an upgrade should be performed. The programmer will complete the device upgrade in approximately 10-20 seconds. During the upgrade process the device continues to function as programmed, with all bradycardia and tachycardia functions fully available.

Approximately 143,000 Epic and Atlas family ICDs have been implanted worldwide since July 2002; approximately 123,000 of these devices remain in service. To date, 8 out of 143,000 of the subject device population (an incidence of 0.00006) have been found to exhibit a loss of ventricular sensing, with a risk of patient harm estimated to be on the order of 1 in 1 million (0.000001).

The loss of ventricular sensing has been attributed to a well defined, yet extremely rare timing sequence that occurs in a very small (61 microsecond) timing window. No patient injuries or deaths have been reported to St. Jude Medical as the result of a device entering the described loss of sensing state. As mentioned above, the potential issue can be fully resolved and eliminated by a programmer initiated upgrade to the device.

In Summary:

A simple programmer software/device firmware upgrade will resolve the issue and prevent a future occurrence. Patients who are followed on a routine basis with scheduled follow-up visits every three to six months should continue with their scheduled visit. Upon interrogation of one of the subject devices, the Merlin and Model 3510 programmers with the newly provided software will automatically identify a device that can benefit from a firmware upgrade and will instruct the clinician that an upgrade is available.

We, along with our independent Medical Advisory board members have determined that no other action is recommended.

REFERENCES

1. Jenney, C., Tan, J. Karicherla, A., Burke, J., & Helland, J. (2005) A new insulation material for cardiac leads with potential for improved performance. Heart Rhythm, 2(Suppl. 5), S318-S319. http://dx.doi.org/10.1016/j.hrthm.2005.02.1004

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