CARDIOVASCULAR
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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.

  • ACCENT™ SR AND ACCENT™ DR PACEMAKERS IMPORTANT INFORMATION–19 APRIL 2013
    Field Safety Notices

    St. Jude Medical 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:

    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:

  • FORTIFY™ ST ICDS IMPORTANT INFORMATION–18 APRIL 2013

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

  • QUICKSITE™ AND QUICKFLEX™ LV CRT LEADS IMPORTANT INFORMATION–4 APRIL 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, 2011

    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 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

    View product information for QuickFlex™ µ and Quartet™ Optim™ leads.

  • EPIC™ AND ATLAS™ ICDS IMPORTANT INFORMATION–16 JANUARY 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 +1-800-722-3774.

    Sincerely, 
    Kathleen Chester 
    Vice President, Regulatory Affairs and Quality Assurance

     
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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