BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL TR

    MDR report key: 2153558 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06997
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 7, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NKE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION WITH NO ALLEGATIONS AGAINST ITS PERFORMANCE. DURING THE CHANGE OUT PROCEDURE, THE FIELD REPRESENTATIVE INDICATED THAT THERE WAS SOME CONFUSION AND THE PHYSICIAN RE-IMPLANTED THIS DEVICE AND PLACED THE NEW DEVICE IN A RETURN KIT TO BE SENT BACK FOR ANALYSIS. THIS WAS NOT DISCOVERED UNTIL POST-PROCEDURE WHEN THE DEVICE WAS TESTED. THE PATIENT WAS BROUGHT BACK FOR A REVISION PROCEDURE AND THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL TR IMPLANTABLE CHF GENERATOR NKE GUIDANT CRM CLONMEL IRELAND H125

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention (B)(4)| (B)(4)| (B)(4)| (B)(4)