BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAINFRAME 8253001 NIM RESPONSE 3.0

    MDR report key: 3027939 · Received March 29, 2013

    Report

    Report Number
    1045254-2013-00314
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    GWF
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4): (1) (B)(4) (NIM CONTACT EMG ENDOTRACHEAL TUBE, 7MM), LOT NOT PROVIDED, DATE OF MANUFACTURE UNKNOWN (2) (B)(4) (PULSATRON II HAND-HELD NERVE LOCATOR/STIMULATOR), LOT NOT PROVIDED, DATE OF MANUFACTURE UNKNOWN.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NIM RESPONSE 3.0 MAINFRAME, A 7MM NIM CONTACT EMG ENDOTRACHEAL TUBE AND A PULSATRON II HAND-HELD NERVE LOCATOR/STIMULATOR WERE INVOLVED IN A HEMITHYROIDECTOMY CASE WHERE A PATIENT INJURY OCCURRED, POSSIBLE RESULTING IN VOCAL CORD PARALYSIS ON BOTH SIDES. A POSITIVE RESPONSE WAS RECEIVED FROM THE NIM ON THE RIGHT SIDE, HOWEVER ONCE THE DOCTOR NOTED THE PATIENT HAD CANCER, HE DECIDED TO DO THE LEFT SIDE. THE DOCTOR COULD NOT ILLICIT A POSITIVE RESPONSE FROM THE NIM ON THE LEFT SIDE, SO THE EMG TUBE PLACEMENT WAS ADJUSTED BUT STILL WITH NO RESPONSE. AT THAT POINT THE PULSATRON WAS USED ON THE LEFT SIDE AND A RESPONSE INDICATING A NERVE WAS RECEIVED. WHEN THE VOCAL CORDS WERE VIEWED USING A FLEXIBLE SCOPE, NEITHER SIDE OF THE CORDS WERE MOVING. IT WAS AT THAT TIME THE PATIENT WAS DETERMINED TO HAVE VOCAL CORD PARALYSIS ON BOTH SIDES AND WAS GIVEN A TRACHEOSTOMY. UPON FOLLOW-UP WITH THE FACILITY, THE PATIENT WAS REPORTED AS RECOVERING WELL WITH NO PERMANENT IMPAIRMENT OR INJURY. THE TRACHEOSTOMY WAS REMOVED ONLY A COUPLE DAYS POST-OP AND THE LEFT SIDE NERVE WAS ALREADY FUNCTIONING NORMAL. THEY ARE ATTRIBUTING THE EVENT TO NERVE FATIGUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130482 MAINFRAME 8253001 NIM RESPONSE 3.0 STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED, INC. 8253001 63183600

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention