BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2050387 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-05019
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    November 4, 2010
    Report Date
    February 18, 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

    THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECEIVED ANTITACHYCARDIA PACING (ATP). THE EPISODE APPEARED TO HAVE OCCURRED IN THE VENTRICULAR TACHYCARDIA (VT) 1 ZONE, WHICH WAS PROGRAMMED AS MONITOR ONLY. TECHNICAL SERVICES DISCUSSED THE EPISODE STARTED IN THE VT-1 ZONE BUT THEN MOVED INTO THE VT ZONE WHICH HAD ATP PROGRAMMED. THE PATIENT ALSO HAD PREVIOUS ATP EPISODES, HOWEVER THE ELECTROGRAMS WERE OVERWRITTEN BY NEWER EPISODES. 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 E102

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR (B)(4)| (B)(4)