BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3092573 · Received May 3, 2013

    Report

    Report Number
    2124215-2013-06097
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    April 11, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE HAD NO TELEMETRY CONDITION THAT WAS NOTED UPON ARRIVAL AT BSC WAS THE RESULT OF A FULLY DEPLETED BATTERY. ONCE THE BATTERY WAS REMOVED FROM THE CIRCUIT THE DEVICE CURRENT WAS NORMAL AND PASSED ALL TESTING. AFTER EXHAUSTIVE ANALYSIS ON THE DEPLETED CELL THE CAUSE OF THE BATTERY DEPLETION COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, INITIAL TESTING CONFIRMED THE DEVICE TO EXHIBIT NO TELEMETRY. ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS EVENT WILL BE UPDATED UPON COMPLETION OF THE ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS RETURNED FOR RELIABILITY ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194882 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR 0184| E102