BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1870553 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-16919
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 26, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1192-06 THRU Z-1194-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXTERNAL VISUAL INSPECTION IDENTIFIED FLUID CONTAMINATION IN THE LEAD BARRELS. THERE WAS A HOLE IN THE RIGHT ATRIAL (RA) POSITIVE SEAL PLUG. ALL OF THE OTHER SEAL PLUGS WERE INTACT AND ALL OF THE SET SCREWS OPERATED NORMALLY. ENGINEERING CALCULATIONS DETERMINED THAT THIS DEVICE DID NOT MEET EXPECTED LONGEVITY. THE DEVICE WAS PUT THROUGH AND PASSED THERAPY VERIFICATION TESTING. A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED END OF LIFE (EOL) AFTER EXPERIENCING ONE CHARGE TIME GREATER THAN 30 SECONDS. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, EOL WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE. THIS ISSUE IS DISCUSSED IN THE Q3 2010 PRODUCT PERFORMANCE REPORT (PPR).

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE DEVICE WAS SUCCESSFULLY INTERROGATED BY BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. THERE WAS NO ELECTIVE REPLACEMENT INDICATOR (ERI) TIMESTAMP AND THE DEVICE HAD TRIGGERED AN END-OF-LIFE (EOL) INDICATOR PRIOR TO THE DATE OF EXPLANT. THE DEVICE IS CURRENTLY UNDERGOING LABORATORY TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM AN IMPLANT FORM THAT THIS DEVICE WAS EXPLANTED FOR UNKNOWN REASONS. THERE WERE NO ALLEGATIONS OR COMPLAINTS AGAINST THE DEVICE'S OPERATION, FUNCTIONALITY OR LONGEVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 0174| T125| 5568| T180