BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1952678 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23520
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    September 29, 2010
    Report Date
    December 6, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTING INAPPROPRIATE SHOCK DID NOT CAUSE AN EXHAUSTION OF RESCUE THERAPY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) RECEIVED INFORMATION FROM A BSC FIELD REPRESENTATIVE THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ASSOCIATED WITH A REPORT OF INAPPROPRIATE SHOCK DUE TO ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE (RVR). THE EPISODE STARTED IN THE VT-1 MONITOR ONLY ZONE AND THEN MOVED UP TO THE VT ZONE. DETECTION ENHANCEMENTS WERE ON BUT SINCE IN REDETECTION, WERE NOT EMPLOYED THOUGH THAT WOULD HAVE INHIBITED IF THEY WERE USED, AS THE RHYTHM HAD BEEN UNSTABLE. A BSC TECHNICAL SERVICES CONSULTANT DISCUSSED PROGRAMMING OPTIONS FOR THE DEVICE'S DETECTION ENHANCEMENTS. THERE WERE NO REPORTS OF ADVERSE PATIENT EFFECTS, AND THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

    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 61 YR 0158| E110| A135| (B)(4)