BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1851964 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14579
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 8, 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

    IT WAS REPORTED THAT THESE PRODUCTS WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP VISIT, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE HAD MOVED FROM THE CHEST CAVITY TO THE ARM PIT OF THE PATIENT. ADDITIONALLY, HIGH THRESHOLD MEASUREMENTS WERE FOUND ON THE LEFT VENTRICULAR (LV) LEAD. FOUR DAYS LATER, THE DEVICE WAS SUBSEQUENTLY EXPLANTED DUE TO A LOW REMAINING BATTERY STATUS, AND THE ADDITIONAL SUSPICION OF INFECTION. A 2 CM WART WAS FOUND IN THE ARMPIT. THE LV LEAD WAS ABANDONED. NO PRODUCTS REMAIN IN SERVICE. A NEW SYSTEM WAS SUCCESSFULLY IMPLANTED ON THE RIGHT SIDE AND PROGRAMMED VVI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H197

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R 6932| MISMATCH| H197| 4542