BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXON PATIENT MODULE

    MDR report key: 3011034 · Received March 14, 2013

    Report

    Report Number
    1045254-2013-00267
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Report Date
    August 3, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    GWF
    PMA / PMN Number
    K061639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL FOUND A DEFECTIVE CONNECTOR BOARD. THE MFG DATE IS UNOBTAINABLE. RECORDS PRIOR TO SEPTEMBER 2011 REMAIN WITH THE ORIGINAL DEVICE MANUFACTURE. THE NIM-ECLIPSE SYSTEM NEUROVASCULAR WORKSTATION IS INTENDED FOR USE TO MONITOR SENSORY AND MOTOR PATHWAYS. 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. THE ECLIPSE PATIENT MODULE SERVES AS AN INTERFACE BETWEEN THE PATIENT AND THE ECLC/CONTROLLER. IT IS DESIGNED TO DELIVER STIMULUS AND RECORD THE READINGS VIA ELECTRODES. WHEN INFO SUGGESTS THAT THE NIM ECLIPSE 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 SERIOUS INJURY, WE ARE FILING THIS REPORT AS A PRODUCT PROBLEM. THE NIM-ECLIPSE SYSTEM DOES NOT PREVENT THE SURGICAL SEVERING OF NERVES. IF MONITORING IS COMPROMISED, THE SURGICAL PRACTITIONER MUST RELY ON ALTERNATE METHODS, OR SURGICAL SKILLS, EXPERIENCE, AND ANATOMICAL KNOWLEDGE TO PREVENT DAMAGE TO NERVES. THIS PRODUCT WAS 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 A PATIENT INTERFACE MODULE FOR SERVICE/REPAIR STATING "NON-SPECIFIC BROKEN." THERE WAS NO SUGGESTION OF PATIENT INJURY. TESTING/REPAIR FOUND A DEFECTIVE CONNECTOR BOARD. THE AVAILABLE INFO INDICATES THE PATIENT MODULE HAD A NON-SPECIFIC MALFUNCTION, WHICH SUGGESTS THAT IT MAY NOT HAVE BEEN STIMULATING/DELIVERING CURRENT, AND THE USER WAS NOT ALERTED BY A SYSTEM ALARM, WARNING SCREEN OR ERROR MESSAGE. EVENT CONTEXT WAS NOT GIVEN. IF THE SYSTEM IS NOT STIMULATING/DELIVERING CURRENT AND THE USER HAS NOT BEEN ALERTED TO THIS MALFUNCTION THIS COULD POTENTIALLY RESULT IN FALSE NEGATIVE. FALSE NEGATIVES COULD POTENTIALLY CAUSE INJURY TO THE PT BY FAILING TO IDENTIFY A NERVE. 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
    108217 AXON PATIENT MODULE GWF- STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED, INC. 945OPM660

    Patients

    Seq Age Sex Outcome Treatment
    1