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PRODUCT ADVISORIES: 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.

Visit the Abbott Neuromodulation website to view products advisories for neuromodulation (chronic pain and deep brain stimulation) products.

  • CONFIRM Rx™ ICM - INABILITY TO PAIR THE IMPLANTED DEVICE IMPORTANT INFORMATION - 20 NOVEMBER 2018
    Physician Communication

    On November 20, 2018, Abbott provided an Urgent Medical Device Correction notice to customers communicating a voluntary recall of a small number of Confirm Rx™ DM3500 Insertable Cardiac Monitors (ICM) subject to a communication issue resulting in the inability to pair the implanted device with the mobile phone app. Please find the below physician communication document for further information.

     

  • CONFIRM Rx™ ICM WITH INCORRECT LOW BATTERY INDICATORS DUE TO COLD TEMPERATURE IMPORTANT INFORMATION – MAY 18, 2018
    Physician Communication

    May 18, 2018 – Abbott recently notified physicians that exposure to sub-freezing temperatures during our supply chain process caused a transient battery voltage drop for a small number of Confirm Rx™  Insertable Cardiac Monitoring (ICM) Model DM3500 devices. Updated Merlin™ programmer software will be made available to allow physicians to detect the presence of an incorrect low battery indicator prior to implant and provide a mechanism to resolve the incorrect display for already implanted devices.

  • IMPLANTABLE CARDIOVERTER DEFIBRILLATOR CYBERSECURITY FIRMWARE UPDATE – APRIL 16, 2018
    Physician Communication

    April 16, 2018 – Abbott 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.

    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.

     

  • PACEMAKER CYBERSECURITY FIRMWARE UPDATE – AUGUST 29, 2017
    Physician Communication

    On August 29, 2017, Abbott 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 in the U.S.: Accent SR RF™, Accent MRI™, Assurity™, Assurity MRI™, Accent DR RF™, Anthem RF™, Allure RF™, Allure Quadra RF™ and Quadra Allure MP RF™.

    Watch the low voltage device firmware cybersecurity update – this video will review the steps to update the device firmware. 

    Patient Communication

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

  • QUICKSITE™ AND QUICKFLEX™ LV CRT LEADS IMPORTANT INFORMATION–APRIL 4, 2012
    Physician communication

    On April 3, 2012, St. Jude Medical provided a Medical Device Advisory and Important Product Information Update to physicians regarding the QuickSite™ and QuickFlex™ LV CRT leads:

    ST. PAUL, Minn.--(BUSINESS WIRE)--Apr. 4, 2012

    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. Abbott releases a semi-annual report detailing overall performance and reliability of its Cardiac Rhythm Management products.

    Current and Archived Product Performance 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

  • EPIC™ AND ATLAS™ ICDS IMPORTANT INFORMATION–JANUARY 16, 2008
    Physician Communication: Important Device Upgrade Information – Epic™ & Atlas™ Family of ICDs

    January 16, 2008

    Dear Doctor,

    St. Jude Medical is 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 Merlin PCS 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.

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

    If you have any questions or would like to discuss this topic in greater detail, please do not hesitate to contact your local Sales Representative or Technical Services at 800-722-3774.

    Sincerely,

    Kathleen Chester
    Vice President, Regulatory Affairs and Quality Assurance

  • ST. JUDE MEDICAL PACEMAKER COMMUNICATION–JANUARY 29, 2014
    Physician communication

    Considerations When Using Electrocautery in Patients Implanted with Older Generation St. Jude Medical™ Pacemakers (Affinity™, Entity™, Integrity™, Identity™, Sustain™, Frontier™, Victory™ and Zephyr™ models)

     

  • AMPLATZER™ SEPTAL OCCLUDER (ASO) IMPORTANT INFORMATION
    Health care professional notification | Soins de santé notification professionnel

    AMPLATZER Septal Occluder (ASO) FDA panel review materials

    The FDA occasionally invites medical manufacturers to review device performance in a public forum to determine if any changes are needed for device labeling or whether any additional data needs to be collected to better understand device performance. St. Jude Medical was invited to the Circulatory System Devices Panel of the Medical Devices Advisory Committee for discussion on May 24, 2012.

    Supporting materials

    Supporting documents for the FDA panel provided by St. Jude Medical include:

    The American College of Cardiology (ACC) guidelines focus on assisting healthcare providers in clinical decision making, defining practices that meet the needs of most patients in most circumstances and supporting the practicing cardiologist in the care of adult congenital heart disease (ACHD) patients:

    The ACC guidelines focus on assisting healthcare providers in clinical decision making, defining practices that meet the needs of most patients in most circumstances and supporting the practicing cardiologist in the care of pediatric patients with congenital heart disease;

    The AMPLATZER Septal Occluder Delivery System Instructions for Use (IFU) was updated in January 2012:

    AMPLATZER Septal Occluder and Delivery System Instructions for Use

    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 cardiovascular 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.

    For more information, contact Abbott’s Cardiovascular Customer Service at 800-544-1664.

    AMPLATZER™ Septal Occluder (ASO) instructions for use updates

    This letter is to inform physicians about important information concerning the AMPLATZER Septal Occluder instructions for use.

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
2. Hayes, D. L., Asirvatham, S. J., & Friedman, P. A. (2008). Cardiac Pacing, Defibrillation and Resynchronization, 2nd Edition, (192), Hoboken, NJ: Wiley-Blackwell.
3. Ellenbogen, K. A., & Wood, M. A. (2005). Cardiac Pacing and ICDs, 4th Edition, (227), Hoboken, NJ: Wiley-Blackwell.

 

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