BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3905682 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11232
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 23, 2013
    Report Date
    May 20, 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). AS OF THIS DATE, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT REMOTE MONITORING OF THIS DEVICE AND RIGHT VENTRICULAR LEAD REVEALED A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT. THIS INFORMATION HAS BEEN PROVIDED TO THE PHYSICIAN AND IS BEING FURTHER MONITORED. ALL OTHER MEASUREMENTS WERE NORMAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED. APPROXIMATELY, ONE YEAR LATER, A REPLACEMENT PROCEDURE WAS PERFORMED. THE RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO NOISE AND THE OUT OF RANGE IMPEDANCE MEASUREMENT. IN ADDITION, INCREASED THRESHOLD MEASUREMENTS WERE OBSERVED. THE PATIENT HAS NOT RECEIVED ANY INAPPROPRIATE SHOCKS. NO PACING INHIBITION WAS REPORTED AS A RESULT OF THIS ISSUE AS THE PATIENT IS PACEMAKER DEPENDENT. THIS DEVICE REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384937 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R 0185| F102