BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3211589 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09418
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A LOOSE HEADER WAS DUE TO A WEAKENED HEADER BOND. THE HEADER WIRES WERE FOUND TO BE FRACTURED. IMPROVEMENTS HAVE BEEN MADE TO THE MANUFACTURING PROCESS IN ORDER TO STRENGTHEN THE BOND BETWEEN THE HEADER AND THE DEVICE CASE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THERE WAS NOISE AND AN AN OUT OF RANGE LEAD IMPEDANCE MEASUREMENT AND A DEVICE HEADER ISSUE WAS SUSPECTED. THE POCKET WAS OPENED AND THE HEADER WAS NOTED TO BE SEPERATED FROM THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE DEVICE WAS REMOVED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310326 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 133 MO Hospitalization| L| R 0049| 0180| E102| 4968