BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2180571 · Received July 27, 2011

    Report

    Report Number
    2124215-2011-12670
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECORDS INDICATE THIS DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS CONCERNED THEIR DEVICE BATTERY WAS DEPLETING PREMATURELY. AT A RECENT FOLLOW-UP APPOINTMENT THEY WERE TOLD THE REMAINING LONGEVITY WAS 18 MONTHS. AT A FOLLOW-UP THREE MONTHS LATER THE REMAINING LONGEVITY WAS 6 MONTHS. THE PATIENT REPORTED THEIR LOWER RATE LIMIT HAD BEEN INCREASED AT THE FIRST FOLLOW-UP APPOINTMENT. ADDITIONALLY, THE PATIENT REPORTED THE HAD RECEIVED INAPPROPRIATE SHOCKS IN THE PAST DUE TO ATRIAL FIBRILLATION (AF). 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 H177

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 4538| 0147| H177| 5594