BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2153147 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06239
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 8, 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

    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 THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECEIVED ANTI TACHYCARDIA PACING (ATP) AND SHOCKS FOR WHAT APPEARED TO BE SINUS TACHYCARDIA. IT WAS NOTED THAT THE PATIENT HAD A VENTRICULAR TACHYCARDIA (VT)-1 ZONE 150 AND WAS A MONITOR ONLY (MO) ZONE. THE EPISODE MET INITIAL DETECTION IN THE MO ZONE AND PROGRESSED UP TO THE VT ZONE OCCASIONALLY. TECHNICAL SERVICES (TS) DISCUSSED PROGRAMMING OPTIONS AND DETECTION ENHANCEMENTS. 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 E110

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR 5568| 5076| 0158| E110| S602