BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3904845 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10133
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 23, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE DEVICE WAS FOUND TO HAVE NO TELEMETRY. THE CAUSE OF THE DEPLETED BATTERY AND NO TELEMETRY CONDITION COULD NOT BE DETERMINED, AS NO HIGH CURRENT DRAIN CONDITION WAS FOUND DURING DETAILED ANALYSIS. NO FIELD ALLEGATION WAS MADE AGAINST DEVICE FUNCTIONALITY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS ELECTIVELY EXPLANTED DURING AN UPGRADE PROCEDURE. THERE WAS NO ALLEGATION FROM THE FIELD REGARDING THE FUNCTION OF THE DEVICE. THIS EVENT WAS CREATED DUE TO THE INITIAL TESTING PERFORMED BY OUR POST MARKET QUALITY ASSURANCE LABORATORY. INITIAL TESTING NOTED A POSSIBLE PERFORMANCE ISSUE.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384108 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR E102| 0185| 4136| E143