BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3083472 · Received April 29, 2013

    Report

    Report Number
    2124215-2013-07068
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, PRODUCT ANALYSIS CONFIRMED THE ALLEGATION OF PREMATURE BATTERY DEPLETION. REMOTE MONITORING SYSTEM DATA SINCE 2009 NOTED THAT THE AVERAGE POWER HAS BEEN ELEVATED. THE DEVICE WAS PUT THROUGH THE RETURNED PRODUCTS TEST AND PASSED THE PACING, SENSING, SHOCKING AND RECORDING FUNCTIONAL TESTS. THE PULSE GENERATOR CASE WAS REMOVED; ALL CURRENT DRAIN MEASUREMENTS WERE WITHIN SPECIFICATION. THE DEVICE WAS PROGRAMMED TO VARIOUS MODES AND NO HIGH CURRENT WAS NOTED. HIGH POWER VISUAL INSPECTION OF THE HYBRID NOTED NO IRREGULARITIES. THE CAUSE OF THE INCREASE AVERAGE POWER CONSUMPTION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. THIS ICD DEVICE WAS EXPLANTED, REPLACED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185726 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 10398 DA Hospitalization| L| R E110| 4470| 0185