BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2053136 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03847
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 2, 2011
    Report Date
    April 8, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DEVICE INTERROGATION REVEALED THAT THE DEVICE BATTERY STATUS WAS [ELECTIVE REPLACEMENT INDICATOR (ERI), WITH A BATTERY VOLTAGE OF 2.2 VOLTS. 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. FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO A COMPROMISED LOW-VOLTAGE CAPACITOR, WHICH RESULTED IN A HIGH CURRENT CONDITION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED. PREMATURE BATTERY DEPLETION WAS ALLEGED. THIS DEVICE WILL BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H230

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention H230