BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2170349 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10525
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR (B)(6) LABORATORY. TELEMETRY COULD NOT BE ESTABLISHED WITH THE DEVICE. AN EXTERNAL POWER SUPPLY WAS CONNECTED TO THE DEVICE AND A HIGHER THAN NORMAL CURRENT DRAIN WAS OBSERVED. IN AN ATTEMPT TO DETERMINE THE CAUSE OF THE HIGH CURRENT CONDITION, ELECTRICAL TESTING AND PHOTO EMISSION MICROSCOPY ANALYSIS WERE CONDUCTED, WHICH ISOLATED THE HIGH CURRENT CONDITION TO AN ANOMALY ON ONE OF THE COMPONENT LAYERS (OXIDE) WITHIN A REGION OF THE DEVICE'S INTEGRATED CIRCUIT CORRESPONDING TO A CAPACITOR. THIS ANOMALY CAUSES A HIGH CURRENT DRAIN, WHICH OVER TIME CAN RESULT IN PREMATURE BATTERY DEPLETION, AS WAS OBSERVED IN THIS CASE. THE BATTERY WAS DEPLETED TO THE POINT THAT TELEMETRY WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE OFFICE VISIT, THIS DEVICE EXHIBITED PREMATURE BATTERY DEPLETION AND WENT FROM EIGHT AND ONE HALF YEARS OF LONGEVITY REMAINING TO ELECTIVE REPLACEMENT INDICATOR (ERI) WITHIN EIGHT MONTHS OF IMPLANT. THE LAST CAPACITOR REFORMATION HAD OCCURRED LESS THAN THREE MONTHS PRIOR. A CAPACITOR REFORMATION BY THE FIELD REPRESENTATIVE WAS PERFORMED, THE DEVICE THEN WENT INTO STORAGE MODE AND WAS UNABLE TO BE INTERROGATED. A REPLACEMENT PROCEDURE WAS PERFORMED WERE THIS DEVICE WAS EXPLANTED AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Life Threatening| R 4472| E110| 0180| T127