BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 4140032 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16497
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 31, 2014
    Report Date
    September 23, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE DEVICE IDENTIFIED AN ARC MARK ON THE DEVICE CASE. REVIEW OF DEVICE MEMORY FOUND A SHORTED LEAD FAULT (FAULT CODE 1004] WAS RECORDED. 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 THE SHOCK THAT RESULTED IN THE SHORTED SHOCK LEAD FAULT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP, THE DEVICE INDICATED AN ERROR CODE FOR A SHORT CIRCUIT CONDITION DETECTED DURING SHOCK DELIVERY. THE DEVICE MEMORY NOTED A VENTRICULAR FIBRILLATION (VF) EPISODE WITH ADEQUATE SHOCK. THE SHOCK IMPEDANCE MEASUREMENT WAS LESS THAN 20 OHMS. ALL OTHER MEASUREMENTS WERE APPROPRIATE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND ENGINEERING REVIEWED THE DEVICE INFORMATION AND CONCLUDED THAT EVEN THOUGH THE PLASMA FUSE MAY BE OPEN, DUE TO THE SHOCK INTO A SHORTED LEAD, THE DAILY AND MANUAL SHOCK IMPEDANCES MAY STILL FUNCTION AND A HIGH ENERGY SHOCK OR CAP REFORM MAY NOT DELIVER THE REQUIRED THERAPY. AS A RESULT, REPLACEMENT WAS RECOMMENDED. THE DEVICE WAS EXPLANTED AND THE LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620278 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R F102| 0175