BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 2161580 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07159
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 29, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILED ANALYSIS IS BEING PERFORMED ON THIS DEVICE. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE INTERROGATED MONITORING VOLTAGE IS 2.45V. THE BATTERY STATUS WAS AT MIDDLE OF LIFE 2 (MOL2). THERE WAS A REVIEW OF THE DEVICE MEMORY, WHICH NOTED NO RESETS OR FAULT CODES. UPON FURTHER REVIEW IT WAS NOTED THAT THE LAST SHOCK DELIVERED WAS 31 JOULES. THERE WERE MANY SHOCKS ATTEMPTED DURING THERAPY VERIFICATION TESTING, ALL ENDED IN CHARGE TIME OUT. A MANUAL CAPACITOR REFORM WAS INITIATED. THE CHARGE TIME WAS 45.1 SECONDS. THEN THE BATTERY STATUS WENT TO END OF LIFE (EOL). ADDITIONAL TESTING WAS DONE AND THE PULSE GENERATOR CASE WAS REMOVED. INTERNAL VISUAL INSPECTION NOTED NO IRREGULARITIES. THE POWER SUPPLY VOLTAGE MEASUREMENTS ARE NORMAL. THE CELL VOLTAGE WAS MONITORED DURING A CAPACITOR REFORM, AND THE VOLTAGE REMAINED AT 2.44V. THE CHARGE WAS NOT OCCURRING. AN EXTERNAL POWER SOURCE WAS SET TO 2.44V AND CONNECTED TO THE CIRCUIT. THE CELL WAS ISOLATED, AND ALL CURRENT MEASUREMENTS WERE NORMAL. THE POWER SOURCE VOLTAGE WAS INCREASED TO 3.25V. ALL CURRENT MEASUREMENTS WERE NORMAL. ANOTHER CAPACITOR REFORM WAS ATTEMPTED. THE DEVICE DID NOT CHARGE. ADDITIONALLY CURVE TRACER MEASUREMENTS NOTED OPEN READINGS FOR ALL DIODES IN THE TRANSFORMER SECONDARY CIRCUITRY. A CLOSE VISUAL INSPECTION OF THE TRANSFORMER NOTED THE COVER WAS LIFTED ON ALL SIDES EXCEPT WERE IT IS SOLDERED DOWN. THIS IS EVIDENCE THAT THE TRANSFORMER SECONDARY WINDINGS HAVE BEEN BROKEN APART. THIS KIND OF DAMAGE OCCURS WHEN THE DEVICE HAS BEEN DROPPED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DID NOT PASS THE RIGHT VENTRICULAR (RV) PACE SHOCK FALBACK TEST PORTION OF RETURNED PRODUCTS TEST, SUGGESTING A POSSIBLE PERFORMANCE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T135

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR T135| 0157