BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2053321 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04053
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    January 31, 2011
    Report Date
    March 4, 2011
    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

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WHEN ATTEMPTING INDUCTION TESTING, TELEMETRY WAS LOST, INDICATED BY FLAT ELECTROGRAMS (EGMS) AND NO FUNCTIONALITY TO END THE TESTING. THE "CANCEL TELEMETRY" BUTTON WAS PUSHED, WHICH STOPPED THE TEST. SUBSEQUENTLY, TELEMETRY WAS OBTAINED AND THE EGM RETURNED. A COMPLETE DEVICE CHECK WAS PERFORMED AND ALL LEAD DIAGNOSTICS AND DEVICE FUNCTION WAS NOTED TO BE NORMAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED. TECHNICAL SERVICES (TS) DISCUSSED THAT THIS SOUNDED LIKE TEXT BOOK TELEMETRY LOSS AND AGREED WITH THE FOLLOW-UP THAT WAS PERFORMED.

    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 79 YR 0148| 4470| T125| E110