BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2170355 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09968
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS FOUND TO BE AT END OF LIFE (EOL) BATTERY STATUS DURING AN INTERROGATION AFTER THE PATIENT RECEIVED APPROPRIATE SHOCK THERAPIES. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED A MANUAL CAPACITOR REFORMATION RESULTED IN A 45 SECOND CHARGE TIME, AND THE PROGRAMMER INDICATED THE DEVICE HAD LIMITED FUNCTIONALITY. A DEVICE DATA DISK WAS SUBMITTED FOR ENGINEERING ANALYSIS, WHICH CONFIRMED THE DEVICE DECLARED EOL STATUS DUE TO AN EXTENDED CHARGE TIME THAT EXCEEDED SPECIFICATIONS. THE DISK ANALYSIS COULD NOT DETERMINE IF THERE WERE ANY OTHER DEVICE OR LEAD ISSUES. BECAUSE THE PATIENT HAS A TERMINAL CANCER AND WAS EXPECTED TO ENTER HOSPICE IN THE NEAR FUTURE, THE PATIENT'S PHYSICIAN ELECTED NOT TO REPLACE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR 0185| E102