BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2040712 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01719
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 10, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ICD REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE THERAPY. PATIENT RECEIVED ONE ANTI-TACHYCARDIA PACING (ATP) THERAPY AND 6 SHOCKS. BOSTON SCIENTIFIC TECHNICAL SERVICES (BSC TS) REVIEWED EPISODES, AND DISCUSSED THAT IT WAS POSSIBLE TO SEE THAT THE EPISODE ONSET OCCURRED WITH A QUITE STABLE RATE AT 375 BEATS/MINUTE (BPM) AND GRADUALLY BECAME UNSTABLE WITH SOME PREMATURE VENTRICULAR CONTRACTION (PVC) CAUSING RHYTHM IDENTIFICATION (RID) DETECTION TO DECLARE UNCORRELATED RHYTHM AT THE END OF THE DURATION. AFTER FIRST ATP DELIVERY, THE RHYTHM HAD NO VARIATION AND GRADUALLY INCREASED TO 165 BPM WITH ALTERNANCE BETWEEN STABLE BEATS AND SOME EXTRA SYSTOLE BEATS. AFTER SHOCK DELIVERY, THE RHYTHM REMAINED AT THE SAME RATE, BUT PROBABLY DUE TO THE SHOCK EFFECT, THE SHOCK CHANNEL MORPHOLOGY WIDENED. FOLLOWING THE 5TH ATTEMPT OF SHOCK DELIVERY, A VT EPISODE STARTED IMMEDIATELY. THIS VT EPISODE ONLY LASTED 4 SECONDS BEFORE RETURNING TO THE INITIAL ATRIAL RATE. BSC TS SUGGESTED THAT THE VT RATE CUT OFF ZONE BE REPROGRAMMED TO PREVENT INAPPROPRIATE TREATMENT FOR ATRIAL FIBRILLATION (AF) EPISODES. LAST DEVICE PROGRAMMING SHOWS THE NEW CUT OFF RATE WAS SET TO 190 BPM. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1