BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 4131627 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14996
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    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

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE ICD IDENTIFIED AN ARC MARK ON THE DEVICE CASE. AN X-RAY OF THE DEVICE REVEALED THAT THE INTERNAL HIGH VOLTAGE FUSE WAS DAMAGED (I.E., NO LONGER INTACT). THE DAMAGE TO THE FUSE MOST LIKELY OCCURRED DURING DELIVERY OF A HIGH ENERGY SHOCK THAT RESULTED IN THE SHORTED SHOCK LEAD FAULT. THE DAMAGE TO THE HIGH VOLTAGE FUSE PREVENTED ANY SUBSEQUENT CHARGING OF THE HIGH VOLTAGE CAPACITORS AND DELIVERY OF SHOCK THERAPY. AS A RESULT, THE HIGH VOLTAGE CHARGE ATTEMPT CAUSED THE DEVICE TO DECLARE EOL BECAUSE IT COULD NOT SUCCESSFULLY COMPLETE CHARGING WITHIN 30 SECONDS. THE ALLEGATIONS REPORTED BY THE FIELD WERE CONFIRMED BY LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO REACHING END OF LIFE (EOL). THERE WAS CONCERN OF PREMATURE BATTERY DEPLETION AND A POSSIBLE ALERT RECORDED IN THE DEVICE MEMORY. THE FIELD REPRESENTATIVE REQUESTED ANALYSIS TO DETERMINE IF THE DEVICE REACHED EOL DUE TO AN ALERT OR HIGH PROGRAMMED OUTPUTS. THE DEVICE HAS BEEN RETURNED FOR LABORATORY ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612536 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R 5076| E110| 7278| 6947