BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2060097 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05696
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THE PATIENT RECEIVED SIX INAPPROPRIATE SHOCKS AND ANTI-TACHYCARDIA PACING DUE TO A CONDUCTED SUPRA VENTRICULAR TACHYCARDIA. BECAUSE THE RATE WAS INITIALLY DETECTED IN THE MONITOR ONLY ZONE AND ACCELERATED INTO THE VT ZONE THE PROGRAMMED DETECTION ENHANCEMENTS DID NOT INHIBIT THERAPY. THE INAPPROPRIATE THERAPY DID NOT CONVERT THE RHYTHM AND THERAPY WAS EXHAUSTED FOR THAT EPISODE. PROGRAMMING AND MEDICATION OPTIONS WERE DISCUSSED. 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 79 YR E102| 0157| 1860