BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2051595 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03225
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    December 14, 2010
    Report Date
    February 20, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES DISCUSSED THE OPPORTUNITY FOR THERAPY OPTIMIZATION VIA PROGRAMMING ENHANCEMENTS TO INCLUDE; TWO ZONE THERAPY PROGRAMMING, ELIMINATING THE MONITORING ONLY AND CHANGING CUT OFF RATES. AS NO FURTHER INFORMATION CONCERNING THIS REPORT HAS BEEN RECEIVED, OUR INVESTIGATION IS COMPLETE AT THIS TIME. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED AN INQUIRY REGARDING A SPECIFIC STORED EPISODE, QUESTIONING WHY ATP HAD BEEN DELIVERED; NOTING RHYTHM IDENTIFICATION (RID) WAS ON AND THREE TACHY ZONES PROGRAMMED. A BOSTON SCIENTIFIC INTERNAL TECHNICAL SERVICE CONSULTANT REVIEWED THE CASE WITH THE FOLLOWING COMMENTS; SINCE THE VT-1 ZONE HAD BEEN PROGRAMMED TO MONITOR ONLY AND THE RHYTHM WAS INITIALLY DETECTED AND DURATION FULFILLED WITHIN THIS ZONE, NO THERAPY HAD BEEN DELIVERED. THE RHYTHM THEN ACCELERATED INTO THE VT ZONE AND WAS CORRECTLY REDETECTED. BEING THAT THIS WAS NOT THE INITIAL DETECTION, NO DETECTION ENHANCEMENTS WERE APPLIED AND ATP DELIVERED. 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 F110

    Patients

    Seq Age Sex Outcome Treatment
    1