BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1944552 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19719
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    August 12, 2010
    Report Date
    October 6, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE REMAINS IN-SERVICE. THE EVENT WILL BE REOPENED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT RECEIVED SHOCK THERAPY. THE CLINIC RN ASKED WHY THE EPISODE WAS NOT DISPLAYED IN LATITUDE. TECHNICAL SERVICES EXPLAINED THAT DEVICE INTERROGATION HAD NOT BEEN PERFORMED POST-SHOCK. BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE FOR SINUS TACHYCARDIA (ST). TECHNICAL SERVICES EXPLAINED THAT DETECTION ENHANCEMENTS ARE NOT AVAILABLE IF THE ARRHYTHMIA ACCELERATES FROM A VT-1 (MONITOR ONLY) ZONE TO A VT ZONE. TECHNICAL SERVICES DISCUSSED PROGRAMMING OPTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)