BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2913161 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16510
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 1, 2013
    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

    TO DATE, THE LEAD REMAINS IN SERVICE AND THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT THE DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A WEAKENED HEADER BOND. X-RAY EXAMINATION WAS PERFORMED. THE HEADER WIRES WERE VERIFIED TO BE DETACHED. 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 DURING A ROUTINE FOLLOW UP THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD REVEALED NOISE AND OVERSENSING ON A STORED ELECTROGRAM (EGM). A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE WAS REMOVED FROM THE SUBPECTORAL REGION. UPON EXTRACTION OF THE DEVICE; FORCE WAS APPLIED TO REMOVE THE CAN. THE PHYSICIAN NOTED, THAT THE HEADER BROKE FROM THE DEVICE AND BLOOD WAS IN THE DEVICE HEADER. AFTER VISUAL INSPECTION OF THE DEVICE A CONNECTOR BLOCK FAILURE WAS OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS EXPLANTED AND REPLACED WHILE THE LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19650 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R