BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1944554 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19619
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) OUT OF RANGE PACING IMPEDANCES, HIGH THRESHOLDS, AND PACING INHIBITION WAS NOTED. THE RIGHT VENTRICULAR LEAD (COMPETITOR) WAS INSPECTED AND NO DAMAGE WAS NOTED. AN INVASIVE PROCEDURE TOOK PLACE AND THE DEVICE AND LEAD WERE RECONNECTED. POST OPERATIVE MEASUREMENTS WERE NORMAL. THE DEVICE AND COMPETITOR LEAD REMAIN IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1