BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1952567 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23514
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    September 2, 2008
    Report Date
    December 6, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A LONGEVITY CALCULATION CONFIRMED THAT THE DEVICE DID NOT MEET LONGEVITY ESTIMATES PROVIDED IN DEVICE LABELING. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. ALL LOW VOLTAGE POWER SUPPLY MEASUREMENTS WERE CURRENTLY WITHIN AN APPROPRIATE RANGE; HOWEVER, FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO LOW VOLTAGE CAPACITOR DEGRADATION, WHICH RESULTED IN A HIGH CURRENT CONDITION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WHICH IS PART OF THE SHORTENED REPLACEMENT WINDOW ADVISORY (B)(4) 2007 POPULATION PRODUCT ADVISORY INITIALLY COMMUNICATED ON (B)(6) 2007, WAS EXPLANTED FOR NORMAL BATTERY DEPLETION WITHOUT ALLEGATION OF PREMATURE BATTERY DEPLETION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H175

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR H175| 4017| 1861| 0154| 4518