BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2072483 · Received April 29, 2011

    Report

    Report Number
    2124215-2011-07559
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    February 4, 2011
    Report Date
    March 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

    PROGRAMMING OPTIONS WERE DISCUSSED. 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 INAPPROPRIATE ANTITACHYCARDIA PACING (ATP) AND AN INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THE RHYTHM WAS INITIALLY DETECTION IN THE VENTRICULAR TACHYCARDIA 1 ZONE AND REDETECTED IN THE VENTRICULAR TACHYCARDIA ZONE. TECHNICAL SERVICES DISCUSSED THAT THERAPY WAS DELIVERED SINCE THE EPISODE WAS IN REDACTION AND INHIBITORS WOULD NOT BE AVAILABLE. 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 61 YR 0185| E102