BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2052168 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03739
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 22, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 CLINIC NURSE CONTACTED TECHNICAL SERVICES TO REQUEST A REVIEW OF A STORED EPISODE IN THIS PATIENT'S ARRHYTHMIA LOGBOOK. THE ARRHYTHMIA WAS INITIALLY DETECTED IN THE VT-1 ZONE WHICH HAD BEEN PROGRAMMED TO MONITOR ONLY. THE ARRHYTHMIA ACCELERATED AND THE PATIENT RECEIVED TWO ATP AND ONE SHOCK DELIVERY FOR WHAT APPEARED TO BE A SUDDEN ONSET OF ATRIAL TACHYCARDIA. TECHNICAL SERVICES DISCUSSED THE AFFECT OF THE DEVICE'S DETECTION ENHANCEMENT WHEN THE ARRHYTHMIA IS INITIALLY DETECTED IN A MONITOR ONLY ZONE. THE CLINIC NURSE INFORMED TECHNICAL SERVICES THAT THE RHYTHM ID (RID) FEATURE WAS REPORTED AS FALSE IN THE VT-1 ZONE. IT APPEARS THAT THE RID DESIGNATION WOULD HAVE CAUSED THE DEVICE TO DELIVER THERAPY IF THE DEVICE HAD BEEN PROGRAMMED TO MONITOR + THERAPY MODE IN THE VT-1 ZONE.

    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 55 YR (B)(4)| (B)(4)| (B)(4)