BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINFRAME 8252001 NIM RESPONSE 2.0

    MDR report key: 2982817 · Received February 25, 2013

    Report

    Report Number
    1045254-2013-00140
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Report Date
    November 27, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS RECEIVED, THE UNIT HAD A CRACKED BEZEL. REPAIR REPLACED A BAD LCD SCREEN, TOUCHSCREEN AND CRACKED BEZEL. THE SYSTEM CRASHED DURING BURN-IN TEST; THE CPU BOARD, MAIN BOARD, AND ISOLATION INVERTER BOARD WERE ALSO REPLACED. WHEN INFO SUGGESTS THAT THE NIM EQUIPMENT HAD THE POTENTIAL TO NOT STIMULATE TO AFFECT ELECTROMYOGRAPHY (EMG), OR TO DETECT EMG, IT IS ASSUMED THAT THE FAILURE WAS DEVICE-RELATED AND MAY HAVE GONE UNDETECTED. IN THIS CASE, THERE IS NO INFO TO SUGGEST AN EVENT COULD NOT BE INTERPRETED FALSELY - THE REPORT IS INCONCLUSIVE AS TO THE CAUSE OF FIELD OBSERVATION. THEREFORE, WITHOUT INFO TO REASONABLY SUGGEST SERIOUS INJURY, OR THAT MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE SEROUS INJURY, WE ARE FILING THIS REPORT AS A PRODUCT PROBLEM. THE NIM SYSTEM IS INTENDED FOR LOCATING AND IDENTIFYING CRANIAL AND PERIPHERAL MOTOR AND MIXED MOTOR-SENSORY NERVES DURING SURGERY, INCLUDING SPINAL CORD AND SPINAL NERVE ROOTS. IF THE SYSTEM FAILS TO PERFORM AS INTENDED, (ESPECIALLY TO EFFECT OR DETECT ELECTROMYOGRAPHIC (EMG) ACTIVITY) IT PRESENTS THE POTENTIAL FOR TEMPORARY OR PERMANENT DAMAGE TO THE NERVE THAT IS PRESENT. THIS PRODUCT IS BEING USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    THE MFR HAS REFINED THE CRITERIA FOR MAKING MDR DECISIONS. UPON A RETROSPECTIVE REVIEW, THE FOLLOWING EVENT IS NOW BELIEVED TO BE REPORTABLE: A CUSTOMER RETURNED AN NIM-RESPONSE 2.0 MAINFRAME STATING "DOES NOT FUNCTION." THERE WAS NO SUGGESTION OF PT INJURY OR INVOLVEMENT. TESTING/REPAIR FOUND A FAILED ISOLATION INVERTER BOARD, MAIN BOARD, CPU BOARD AND DISPLAY SCREEN. A FAILED ISOLATION INVERTER BOARD, WHICH HAS BEEN KNOWN TO AFFECT THE DELIVERY OF STIMULUS CURRENT, HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PT INJURY (LOSS OF STIMULATION DURING USE LEADING TO A FALSE NEGATIVE) - AS A SUDDEN FAILURE IS NOT CONSISTENTLY ACCOMPANIED BY WARNING/ERROR MESSAGES DURING A PROCEDURE. AT THIS TIME WE ARE UNABLE TO CONFIRM WHETHER THE CUSTOMER RECEIVED ANY ERROR MESSAGES OR ALERTS OF THE FAULT. THIS REPORTED EVENT HAS NO REFERENCE TO AN ALARM OR WARNING, THEREFORE, IT MUST BE ASSUMED THAT AN ALARM OR WARNING WENT UNDETECTED OR DID NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78980 MAINFRAME 8252001 NIM RESPONSE 2.0 ETN MEDTRONIC XOMED, INC. 8252001IP 57267200

    Patients

    Seq Age Sex Outcome Treatment
    1