BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2173132 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10395
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 15, 2011
    Report Date
    July 15, 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

    A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED END OF LIFE (EOL) AFTER EXPERIENCING ONE CHARGE TIME GREATER THAN 30 SECONDS. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, EOL WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

    Description of Event or Problem · 1

    BOSOTN SCIENTIFIC RECIEVED INFORMATION THAT THIS CARDIAC RESYCHRONIZATION THEARPY DEFIBRILLATOR (CRT-D) DECLARED END OF LIFE (EOL) DUE TO EXTENDED CHARGE TIMES. THE DEVICE WILL BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED FOLLOWING THE EXPLANT PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention