BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1862129 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-16804
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 28, 2010
    Report Date
    October 27, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT ALREADY SUBMITTED ON THE SAME ISSUE AND DEVICE. WILL CANCEL THIS EVENT, REFERENCE REPORT 2124215-2010-02686

    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 INTERMITTENT OUT OF RANGE PACING IMPEDANCES WERE NOTED ON THIS RIGHT VENTRICULAR (RV) LEAD ASSOCIATED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). AT THIS TIME NO ADDITIONAL INFORMATION IS AVAILABLE. 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 F110

    Patients

    Seq Age Sex Outcome Treatment
    1