BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1962244 · Received January 18, 2011

    Report

    Report Number
    2124215-2011-00781
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 23, 2007
    Report Date
    January 25, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED TOOL MARKS IN THE HEADER SURFACE. THE NEGATIVE HIGH VOLTAGE SETSCREW WAS STUCK IN THE UP POSITION. ALL OTHER SETSCREWS MOVED FREELY AND OPERATED NORMALLY. THE CAUSE OF STUCK SETSCREW IS CONSISTENT WITH INDUCED DAMAGE. THE DEVICE WAS THEN 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPEDANCE MEASUREMENTS ON THE SHOCK PORTION OF THIS DEFIBRILLATION LEAD WERE PREVIOUSLY NOTED TO BE GREATER THAN 125 OHMS. IT WAS NOTED THAT SOME OF THE MEASUREMENTS WERE NORMAL BUT THEN WENT OUT OF RANGE. ALL OTHER LEAD MEASUREMENTS WERE STABLE AND WITHIN NORMAL LIMITS. THE LEAD WAS REPOSITIONED AFTER WHICH TIME DEFIBRILLATION TESTING FOUND THAT WITH BOTH A 21 JOULE AND 31 JOULE SHOCK THE RESULTANT MEASUREMENT WAS 46 OHMS. THE LEAD CONTINUED TO BE MONITORED WITH NON-INVASIVE PROGRAMMED STIMULATION (NIPS) TESTING DUE TO SOME VARIATION IN SHOCK IMPEDANCE MEASUREMENTS, HOWEVER WITH THE NIPS TEST, A MEASUREMENT OF 40 OHMS WAS TYPICALLY REPORTED. THE PATIENT'S DEVICE WAS LATER EXPLANTED DUE TO NORMAL BATTERY DEPLETION. DURING THE EXPLANT PROCEDURE, THE PHYSICIAN TUGGED ON THE CHRONIC RIGHT VENTRICULAR (RV) LEAD AND IT CAME RIGHT OUT OF THE PORT. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED WITH THE CHRONIC RV LEAD AND THE SET SCREWS WERE SECURELY TIGHTENED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T125

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 0185| 4469| T125