BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAINFRAME NIM RESPONSE 3.0

    MDR report key: 2180468 · Received July 27, 2011

    Report

    Report Number
    1045254-2011-00052
    Event Type
    Injury
    Date Received
    July 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS NOT BEING USED FOR DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    (B)(4): INTERVENTION TO SERIOUS INJURY. A REVIEW OF THE DEVICE HISTORY REPORT DID NOT FIND ANY ABNORMALITIES IN THE PRODUCTION OF THE REPORTED LOT. NO QUALITY NON-CONFORMANCE REPORTS WERE ISSUED DURING THE MANUFACTURING PROCESS FOR THIS LOT.

    Description of Event or Problem · 1

    DESCRIPTION OF REPORTED EVENT: IT WAS REPORTED AFTER A THYROID PROCEDURE, THE PATIENT CLAIMED TO BE EXPERIENCING LARYNGEAL PARALYSIS. RELEVANT EVENTS AND INFORMATION: IT WAS REPORTED THAT DURING THE THYROID PROCEDURE, THE DOCTOR NOTED HE WAS NOT NEAR THE RECURRENT LARYNGEAL NERVE, "SO DID NOT NEED TO USE THE NIM STIMULATOR PROBE." IT WAS ALSO NOTED HE DID NOT VISUALIZE THE NERVE AT ANY TIME DURING THE PROCEDURE. SOMETIME AFTER THE THYROID PROCEDURE WAS PERFORMED, A FOLLOW UP LARYNGEAL EXAM WAS DONE. DURING THE PROCEDURE, A UNILATERAL PARALYSIS ON THE OPERATIVE SIDE WAS OBSERVED AND IT WAS NOTED THE SURGICAL FIELD WAS HEAVILY SCARRED FROM A PREVIOUS PROCEDURE. THE DOCTOR REPORTED THE PATIENT HAS DECIDED TO SEEK FOLLOW-UP TREATMENT ELSEWHERE AND THE PATIENT'S CURRENT CONDITION IS NOT KNOWN. AFTER THE CASE, THE DOCTOR CONTACTED THE NIM MANUFACTURER TO REQUEST INFORMATION ON INTERPRETING THE NIM READOUT DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAINFRAME NIM RESPONSE 3.0 STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001 68863400

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention