BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2041124 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00668
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 30, 2009
    Report Date
    January 10, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN REQUESTS WERE MADE FOR THIS DEVICE. IT WAS LATER REPORTED THE DEVICE WOULD NOT BE RETURNED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED AN INQUIRY PERTAINING TO THE REMAINING LONGEVITY OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITH THE CURRENT VOLTAGE OF 2.61. THE PATIENT WAS BEING MONITORED VIA LATITUDE DUE TO A NON-BOSTON SCIENTIFIC DEFIBRILLATION LEAD ISSUE. IT WAS LATER REPORTED THAT THIS DEVICE WAS EXPLANTED OVER A YEAR AND A HALF LATER FOR NORMAL BATTERY DEPLETION. HOWEVER, DURING THE EXPLANT THE RATE/SENSE SET SCREW WAS LOCKED IN THE DOWN POSITION. THE PHYSICIAN WAS UNABLE TO LOOSEN THE SETSCREW USING MULTIPLE ATTEMPTS AND WRENCH KITS. THE PHYSICIAN ELECTED TO CUT THE NON-BOSTON SCIENTIFIC LEAD FREE LEAD FROM THE HEADER. THE COILS OF THIS NON-BOSTON SCIENTIFIC LEAD ARE STILL IN-SERVICE FOR SHOCKING. A PREVIOUSLY ABANDONED NON-BOSTON SCIENTIFIC LEAD WAS UNCAPPED AND USED FOR THE RATE/SENSE FUNCTION. 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 70 YR Required Intervention 1283| 5024| 1148T| 6949| MISMATCH| H177