BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1954172 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24240
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 16, 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 LATITUDE RED ALERT WAS GENERATED DUE TO HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THIS IS THE INFORMATION KNOWN AT THIS TIME. ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE AND LEAD REMAIN IMPLANTED AND IN SERVICE. 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 1308 MO Other MISMATCH| 0301