BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1041608 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31941
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    November 6, 2006
    Report Date
    July 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z47/55-07
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REGARDING (B)(4): AS OF TODAY, THE EXPLANTED PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. IF IT IS RETURNED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE REOPENED. REGARDING (B)(4): BOSTON SCIENTIFIC CRM RECEIVED TEMPORARY ACCESS TO THIS DEVICE FOLLOWING LITIGATION PROCEEDINGS. VISUAL INSPECTION NOTED THAT THE LEADS WERE ATTACHED TO THE DEVICE BUT SEVERED. UPON INTERROGATION IT WAS NOTED THAT THE DEVICE WAS LEFT IN MONITOR+THERAPY MODE FOLLOWING EXPLANT. THERE WAS AN OPEN LEAD SHOCK FAULT CODE PRESENT UPON INTERROGATION. THE DEVICE WAS RETURNED BACK TO THE PATIENT'S ATTORNEY. THE DEVICE HAS SINCE BEEN RETURNED AGAIN TO BOSTON SCIENTIFIC FOLLOWING THE SETTLEMENT OF THIS LEGAL CASE. THE DEVICE IS CURRENTLY IN ANALYSIS. WHEN ANALYSIS IS COMPLETE, THIS REPORT WILL BE UPDATED. A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE WAS EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED FOR NORMAL BATTERY DEPLETION AND REPLACED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THIS CRT-D WAS LATER EXPLANTED FOR AN UNKNOWN REASON. NEW INFORMATION RECEIVED INDICATES THAT THE PATIENT HAS SINCE RETAINED LEGAL COUNSEL AND FILED A LAWSUIT. THERE WERE NO SPECIFIC ALLEGATIONS AGAINST THE FUNCTIONALITY OF THE DEVICE WITHIN THE LEGAL CLAIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H170 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other THE DEVICE 0125/215661 WAS IMPLANTED 15-APR-1997| THE DEVICE 4470/507563 WAS IMPLANTED 04-APR-2006| THE DEVICE (B)(4) WAS IMPLANTED (B)(6) 2006| THE DEVICE (B)(4) WAS IMPLANTED (B)(6) 1997| THE DEVICE (B)(4) WAS IMPLANTED (B)(6) 2006| THE DEVICE 4543/117080 WAS IMPLANTED 04-APR-2006