BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 1201377 · Received October 16, 2008

    Report

    Report Number
    1717344-2008-00471
    Event Type
    Death
    Date Received
    October 16, 2008
    Date of Event
    March 2, 2006
    Report Date
    August 5, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE NOTICE OF LITIGATION REPORTED THE PT ENTERED SURGERY FOR REPAIR OF A 5 CM ABDOMINAL AORTIC ANEURYSM. THE PT HAD A MEDTRONIC DEEP BRAIN STIMULATOR IMPLANTED IN THE THALAMUS PORTION OF HIS BRAIN AND AN IMPLANTABLE CARDIAC DEFIBRILLATOR. THE PREOPERATIVE CHECKLIST SHOWS THE DEFIBRILLATOR WAS TURNED OFF PRIOR TO SURGERY. HOWEVER, IT MAKES NO MENTION OF THE DEEP BRAIN STIMULATOR BEING TURNED OFF. THE SURGERY USED A FORCEFXC AND A FORCEFX WAS APPARENTLY ALSO PRESENT AND USED. THE COMPLAINT ALLEGES THAT NOT TURNING OFF HIS DEEP BRIAN STIMULATOR RESULTED IN SEVERE BRAIN INJURIES WHEN THE ELECTRICAL CURRENT PASSED THROUGH HIS BODY. IT IS ALSO ALLEGED THAT HE SUFFERED NERVE DAMAGE AND/OR BURNS ON HIS HEELS AND BUTTOCKS. IN 2006, PLAINTIFF WAS DISCHARGED AND PLACED IN A FACILITY IN A CATATONIC/BEDRIDDEN STATE UNTIL HIS DEATH. IT IS UNDETERMINED WHICH ESU IS ALLEGED TO HAVE CAUSED THE BRAIN DAMAGE AND/OR THE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE FX-C GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death FORCEFX| MEDTRONIC DEEP BRAIN STIMULATOR