BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3210385 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09201
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE DELIVERED SEVERAL SHOCK. THE RHYTHM STARTED IN A MONITOR ONLY ZONE AND THEN ACCELERATED INTO THE VENTRICULAR TACHYCARDIA (VT) THERAPY ZONE WHERE SUSTAINED RATE DURATION (SRD) AND ANTI-TACHYCARDIA PACING (ATP) BOTH TIMED OUT. MULTIPLE SHOCKS WERE THEN DELIVERED AND THERAPY WAS EXHAUSTED. IT WAS THOUGHT THAT THE RHYTHM WAS LIKELY AN SUPRAVENTRICULAR TACHYCARDIA (SVT). ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S MEDICATIONS WERE BEING ADJUSTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309803 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 10530 DA T175| E110| 4136| 0185