BEUDAMED
    FDA Adverse Event Death Summary report: N

    TELIGEN IS-1/DF-1 - DR

    MDR report key: 1210804 · Received October 23, 2008

    Report

    Report Number
    2124215-2008-99943
    Event Type
    Death
    Date Received
    October 23, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 23, 2008
    Manufacturer
    CLONMEL
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. POST INDUCTION, THE R-WAVES WERE AROUND 4.3MV. THE BSC REP STATED AFTER THE FIRST INDUCTION, THE DEVICE WAS REPROGRAMMED, YET UNDERSENSING OF THE FIBRILLATION CONTINUED AND STATED THAT THE PATIENT WAS SHOCKED MANY TIMES AT MAXIMUM ENERGY. THE PATIENT WAS SUCCESSFULLY CARDIOVERTED FOLLOWING INDUCTION. DROP OUT OF FIBRILLATION WAVES BELOW 0.3MV OCCURRED. THE SENSITIVITY SETTINGS COULD NOT SENSE AN ARRHYTHMIA AT THAT LEVEL. IT WAS NOTED THAT THERE WERE NO ALLEGATIONS AGAINST DEVICE FUNCTION. A SAVE-TO-DISK WAS ANALYZED BY TECH SERVICES. IN ONE OF THE EPISODES THERE WAS ONE BEAT OF UNDERSENSING NOTED ON THE ONSET EGM. THIS DID NOT DELAY THE INITIAL THERAPY THAT WAS PROGRAMMED. UNDERSENSING WAS CONFIRMED ON SUBSEQUENT EPISODES DUE TO PROGRAMMED SETTINGS. THIS WAS NOTED TO BE NORMAL DEVICE OPERATION BASED ON DUAL CHAMBER PACING AT CYCLES OF 760-513MS. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE PATIENT PASSED AWAY. AT THE TIME OF THE IMPLANT, THE PATIENT'S HEART RATE WAS IN A VARIABLE RATE VENTRICULAR FIBRILLATION (VF). THE DEVICE REACHED DETECTION EVENTUALLY AND DELIVERED ANTI-TACHY PACING (ATP). THE MD THEN GAVE A COMMANDED EXTERNAL SHOCK, WHICH SUCCESSFULLY CONVERTED. THE DEVICE CONTINUED PACING. AFTER THE COMMANDED SHOCK, THE PATIENT HAD NO PRESSURE, AND THE PULSE OXIMETER DROPPED. BLOOD PRESSURE WAS NEVER CONFIRMED FOLLOWING THE COMMANDED SHOCK. THE PATIENT WENT BACK INTO VF, AND THE DEVICE UNDER SENSED THE RATE. THE LEAD MEASUREMENTS PRIOR TO INDUCTION WERE REPORTEDLY NORMAL WITH P WAVES AT 2.5MV, R WAVES RANGING FROM 10/13MV TO 8MV. SENSITIVITY WAS PROGRAMMED AT 0.6MV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IS-1/DF-1 - DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CLONMEL E110

    Patients

    Seq Age Sex Outcome Treatment
    1 Death