BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXON ECLIPSE CONTROLLER

    MDR report key: 3387019 · Received October 4, 2013

    Report

    Report Number
    1045254-2013-00531
    Event Type
    Injury
    Date Received
    October 4, 2013
    Date of Event
    September 9, 2013
    Report Date
    December 11, 2013
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    GWF
    PMA / PMN Number
    K061639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. ALL PRODUCTS WERE USED IN THE SURGERY IN WHICH THE PATIENT WAS INJURED. UNTIL EVALUATED, THERE IS NO WAY OF KNOWING IF THERE ARE PROBLEMS WITH THE PRODUCTS LISTED, SO THEY WILL BE LISTED AS CONCOMITANT DEVICES IN THIS EVENT: PROBE SPK1004 SURGEON CONTROLLED (SPK1004), SERIAL# AND LOT# UNKNOWN, 510K: K062996 MFR. DATE UNAVAILABLE; MODULE OPM660 PATIENT (OPM660), SERIAL# (B)(4), LOT# 1699788, 510K: K061639 MFR. DATE: APRIL 7, 2011; PROBE MDP201 MUTE DETECTOR (MDP201), SERIAL# (B)(4), LOT# 1699866, K061639 MFR. DATE: NOT AVAILABLE; PROBE 8225769 NIM X-PAK (8225769), SERIAL# AND LOT # UNAVAILABLE, K061639 MFR. DATE: NOT AVAILABLE; COMPUTER NCCPU NOTEBOOK (NCCPU), SERIAL# (B)(4), LOT# 1700196, K061639 MFR. DATE: NOT AVAILABLE. (B)(4). THE DEVICES INVOLVED HAVE NOT BEEN RETURNED FOR EVALUATION AT THIS POINT. METHOD: NO TESTING METHODS PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, A TOTAL OF 2 DEVICES AND A CD WERE RETURNED TO THE MANUFACTURER FOR EVALUATION PURPOSES. ANALYSIS RESULTS ARE DETAILED AS FOLLOWS: SPK1004 (QUANTITY 1) ¿ RECEIVED PRODUCT WITHOUT THE ORIGINAL PRODUCT POUCH/BOX OR LABEL. PRODUCT WAS IDENTIFIED TO BE THE SURGEON CONTROLLED STIMULATOR PROBE KIT, WHICH CONTAINS THREE PROBES WITH THE HANDLE ASSEMBLY. THERE WERE NO OBVIOUS SIGNS OF BIO-RESIDUE PRESENT ON THE PRODUCT BUT SINCE THE PRODUCT WAS FOUND OUTSIDE ITS ORIGINAL PACKAGING, IT IS POSSIBLE THAT THE CUSTOMER LIKELY HANDLED/USED THE PRODUCT. ALL THREE PROBES WERE ATTACHED TO THE HANDLE ASSEMBLY AND FUNCTIONALLY TESTED, PASSING THE INSPECTION WITHOUT ANY ISSUES. THE PROBES AND HANDLE PHYSICALLY APPEARED TO BE FREE OF ANY DAMAGE (NO INSULATION OR TIP ISSUES WERE OBSERVED). THE COMPLAINT WAS NOT CONFIRMED FOR ANY MALFUNCTION PERTAINING TO THE PROBE AND THE HANDLE ASSEMBLY. BASED ON OBSERVATIONS, SINCE NO FAULT WAS FOUND ON THE RETURNED PROBE AND HANDLE ASSEMBLY, THE ROOT CAUSE FOR THE COMPLAINT IS NOT EVIDENT AS THE FAILURE IS UNCONFIRMED. FOR 8225769 (QUANTITY 1) ¿ RECEIVED PRODUCT WITHOUT THE ORIGINAL PRODUCT POUCH/BOX OR LABEL. PRODUCT WAS IDENTIFIED TO BE AS THE NIM X-PAK PROBE. THERE WAS NO BIO-RESIDUE PRESENT ON THE PRODUCT TO INDICATE USE. NO VISUAL DAMAGES WERE NOTICED ON THE PRODUCT WITH THE UNAIDED EYE. BASED ON OBSERVATIONS, THE COMPLAINT WAS NOT CONFIRMED SINCE NO FAULT WAS FOUND ON THE RETURNED PROBE... THE ROOT CAUSE FOR THE COMPLAINT IS NOT EVIDENT AS THE FAILURE IS UNCONFIRMED. CD (QUANTITY 1) ¿ THE CD CONTAINED LIVE MONITORING RECORDED BY THE NIM-ECLIPSE SYSTEM FROM THE SURGERY IN WHICH THE EVENT OCCURRED. THE RESULTS WERE AS FOLLOWS: SURGEON DIRECTED STIMULUS SETTINGS APPEARED NORMAL AND THE NERVE RESPONSES IN THE DATA LOG WERE TYPICAL PATIENT NERVE RESPONSES... THERE WAS NOTHING IN THE DATA SET THAT WOULD INDICATE A HARDWARE OR SOFTWARE MALFUNCTION OF THE NIM-ECLIPSE SYSTEM. (B)(4).

    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 THE SURGEON ¿USED ECLIPSE (INTRA OPERATIVE NERVE MONITORING) DURING OBLIQUE LUMBAR INTERBODY FUSION PROCEDURE, FOR PREVENT NERVE INJURY DURING BLIND STEP, BUT PATIENT HAD NERVE INJURY AT L5.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502199 AXON ECLIPSE CONTROLLER STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED, INC ECLC

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention| S