BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3053168 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04498
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 7, 2013
    Report Date
    April 9, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY EVALUATED. VISUAL INSPECTION OF THE DEVICE HEADER AND CASE DID NOT REVEAL ANY ANOMALIES. IT WAS CONFIRMED THAT THE DEVICE HAD NO TELEMETRY AND A MEMORY DOWNLOAD COULD NOT BE PERFORMED. THE DEVICE CASE WAS OPENED IN ORDER TO ASSESS THE INTERNAL COMPONENTS. INITIAL ELECTRICAL TESTING REVEALED THAT THE TRANSFORMER HAD FAILED, RESULTING IN ELECTRICAL OVERSTRESS DAMAGE TO THE POWER SUPPLY CIRCUITRY. DETAILED ANALYSIS DETERMINED THE INABILITY TO INTERROGATE THIS DEVICE WAS DUE TO THE ELECTRICAL OVERSTRESS DAMAGE. THIS RESULTED IN A HIGH CURRENT DRAIN, WHICH DEPLETED THE BATTERY MORE QUICKLY THAN EXPECTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) COULD NOT BE INTERROGATED. VARIOUS TROUBLESHOOTING TECHNIQUES WERE ATTEMPTED BUT WERE UNSUCCESSFUL. AN INVASIVE PROCEDURE WAS PERFORMED. THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156524 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R 0157| E102