BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 3043596 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02399
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    July 10, 2010
    Report Date
    February 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE ANALYSIS, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A LONGEVITY CALCULATION CONFIRMED THE DEVICE DID NOT MEET LONGEVITY ESTIMATES PROVIDED IN DEVICE LABELING. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED 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 PRODUCT WAS RETURNED WITH NO REPORTED PRODUCT PERFORMANCE ISSUES AND NO REPORTED ADVERSE PATIENT EFFECTS. INITIAL ANALYSIS COMPLETED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY DETERMINED THIS PRODUCT DID NOT MEET LONGEVITY EXPECTATIONS. FURTHER ANALYSIS WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147104 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H190

    Patients

    Seq Age Sex Outcome Treatment
    1