BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3971344 · Received July 31, 2014

    Report

    Report Number
    2124215-2014-14855
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    April 11, 2014
    Report Date
    June 10, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RECORDS INDICATE 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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LISTED OVER 67 MILLION VENTRICULAR TACHYCARDIA (VT) EVENTS IN THE DEVICE COUNTERS, HOWEVER THERE WERE NO EPISODES IN THE ARRHYTHMIA LOGBOOK. ANALYSIS OF DEVICE DATA FOUND A SINGLE MEMORY ERROR WHICH EFFECTED THE DEVICE COUNTERS. THIS ERROR WAS DIAGNOSTIC AND DOES NOT EFFECT DEVICE OPERATION OR THERAPY AVAILABILITY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446721 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR E102| 0170| 0180