BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1950959 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23022
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 23, 2010
    Report Date
    November 22, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 A RED ALERT WAS DETECTED DUE TO HIGH OUT OF RANGE PACING IMPEDANCES ON THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND COMPETITOR RIGHT VENTRICULAR LEAD. A FOLLOW UP TOOK PLACE NO NOISE WAS SEEN AND UPON OPENING THE POCKET VISUAL INSPECTION OF THE LEAD AND DEVICE CONNECTION APPEARED NORMAL. THE SETSCREWS WERE LOOSENED AND THE LEAD WAS TESTED WITH A PACING SYSTEM ANALYZER (PSA) WHICH SHOWED NORMAL VALUES. THE COMPETITOR LEAD WAS RE-CONNECTED TO THE DEVICE AND NORMAL VALUES WERE SEEN. A POSSIBLE LEAD ISSUE OR A CONNECTION ISSUE WAS SUSPECTED. AT THIS TIME 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