BEUDAMED
    FDA Adverse Event Death Summary report: N

    TELIGEN

    MDR report key: 1705150 · Received June 1, 2010

    Report

    Report Number
    2124215-2010-11551
    Event Type
    Death
    Date Received
    June 1, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 17, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT EXPLANTED FOLLOWING THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A ROUTINE CHANGE OUT PROCEDURE, THE PATIENT IMPLANTED WITH THIS DEVICE DIED. IT WAS REPORTED THAT IN PREPARATION FOR DEFIBRILLATION THRESHOLD TESTING THE IMPLANTING PHYSICIAN ASKED FOR THE PATIENT¿S BLOOD PRESSURE. THE PATIENT¿S BLOOD PRESSURE HAD BEEN 90/60 THROUGHOUT THE CASE; HOWEVER, THE ANESTHESIOLOGIST COULD NO LONGER ASCERTAIN A READING. UP UNTIL THEN DEVICE WAS "OFF.¿ NO PULSE WAS NOTED. CODE WAS CALLED AND CHEST COMPRESSIONS WERE STARTED. IT WAS THEN NOTED THAT THE PATIENT WAS GOING INTO VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION. THE DEVICE WAS PROGRAMMED TO ¿MONITOR + THERAPY.¿ MULTIPLE CARDIOVERSIONS WERE UNSUCCESSFULLY ATTEMPTED. A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED AND CONFIRMED THAT THE PATIENT WAS IN PULSELESS ELECTRICAL ACTIVITY. THERE WERE NO ALLEGATIONS AGAINST THE FUNCTIONALITY OF THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death E110| 0184| 4469| A155