BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1041911 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34734
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 23, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z47/53-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, LABORATORY TECHNICIANS UTILIZED AN ENGINEERING LEVEL LONGEVITY PREDICTION CALCULATION TO ASSESS THE RATE OF BATTERY DEPLETION, GIVEN THE PROGRAMMED PARAMETERS AND OTHER DATA STORED WITHIN THE MEMORY OF THE DEVICE. THE RESULTS OF THIS CALCULATION INDICATED THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE. NEXT, A COMPREHENSIVE SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS. HAVING MET THE ENGINEERING LONGEVITY PREDICTION, FUNCTIONALLY PASSING ALL RETURNED PRODUCT TESTING, AND WITH NO FURTHER INFORMATION TO INDICATE A PRODUCT PERFORMANCE ISSUE, WE HAVE CONCLUDED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), WHICH BELONGS TO THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY POPULATION, DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) WITH A VOLTAGE OF 2.47 V AND A CHARGE TIME OF 8.2 SECONDS. THERE WAS CONCERN THAT THE DEVICE DID NOT LAST AS LONG AS EXPECTED. THIS CRT-D WAS EXPLANTED AND REPLACED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE DEVICE WAS RETURNED APPROXIMATELY THREE YEARS LATER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H170 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention THE DEVICE 1861/(B)(4)| THE DEVICE 4193/BAA077 WAS IMPLANTED 29-APR-2004| THE DEVICE 4538/151498 WAS IMPLANTED 29-APR-2004| THE DEVICE 4470/347688 WAS IMPLANTED 03-FEB-2003| THE DEVICE H220/509623 WAS IMPLANTED 04-APR-2008| THE DEVICE 4193/(B)(4)| THE DEVICE H220/(B)(4)| THE DEVICE 0158/(B)(4)| THE DEVICE 4470/(B)(4)| THE DEVICE 4538/(B)(4)| THE DEVICE 0158/109082 WAS IMPLANTED 03-FEB-2003| THE DEVICE 1861/243063 WAS IMPLANTED 03-FEB-2003