BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM-ECLIPSE® CONTROLLER

    MDR report key: 7283666 · Received February 20, 2018

    Report

    Report Number
    1045254-2018-00061
    Event Type
    Injury
    Date Received
    February 20, 2018
    Date of Event
    January 22, 2018
    Report Date
    February 20, 2018
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00643169378469
    PMA / PMN Number
    K061639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: * OPM660: MODULE OPM660 PATIENT, S/N (B)(4), LOT 210297648 510K: K061639 (B)(4) MANUFACTURED: 2015-10-19 * NCCPU-FR: COMPUTER NCCPU-FR NOTEBOOK FRENCH, S/N (B)(4), LOT 208250891, 510K: K061639 (B)(4) MANUFACTURED: 2014-04-14 * MDP201: PROBE MDP201 MUTE DETECTOR, S/N (B)(4), LOT 210181662, 510K: K061639 (B)(4) MANUFACTURED: 2015-09-24. PRODUCT EVALUATION: ANALYSIS RESULTS ARE NOT AVAILABLE; THE DEVICE WAS NOT RETURNED FOR EVALUATION. * NOTE: THE REPORTER OF THIS EVENT STATED THAT THERE WAS ¿NO FEEDBACK THAT DOCUMENTED A CHANGE IN LATENCY AND/OR AMPLITUDE AT THE THORACIC PEDICLE SCREW SITE¿. THE DATA SAVED FROM THE NIM ECLIPSE DURING THE PROCEDURE INDICATES THE SYSTEM DISPLAYED A LOWERED MEP READING ON THE R SIDE WHICH SHOULD HAVE ALERTED THE USER TO FURTHER ANALYZE THE DATA AND PEDICLE SCREW SITE TO MEDICALLY ASSESS THE NEED FOR REVISION DURING THE PROCEDURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT FOR A PROCEDURE TO ADDRESS SCOLIOSIS, THEY USED THE NEUROMONITORING SYS NIM ECLIPSE (SD MODE, TRANSCRANIAL MOTOR-EVOKED POTENTIALS (TCMEPS)MODALITY AND EMG) AND AFTER VERIFICATION OF ALL THE TEST REALIZED IN THE OR ESPECIALLY AFTER THE PLACEMENT OF THIS THORACIC PEDICLE SCREWS AND ALL THE CORRECTION DONE AFTER THERE IS NO SIGNIFICANT CHANGE IN THE GRAPH. "REFERRING TO THE DATA SAVED DURING THE PROCEDURE AND ALL THE PROCEDURE ITSELF THERE IS NO FEEDBACK THAT DOCUMENTED A CHANGE IN LATENCY AND/OR AMPLITUDE AT THE THORACIC PEDICLE SCREW SITE". AFTER WAKING, THE PATIENT EXPERIENCED "PARAPLEGIA": "A SPINAL CORD INJURY WAS HAPPENED AFTER A THORACIC PEDICLE SCREW MIGRATION (BREACH)." THIS RESULTED IN A REVISION SURGERY FOR THE PATIENT, IN WHICH THE ASSOCIATED PEDICLE SCREW WAS REMOVED. IT HAS BEEN CONFIRMED THAT "THE MEDICAL CONDITION OF THIS PATIENT HAD IMPROVED AND MOTOR DEFICITS (LOWER LIMBS) DISAPPEARED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126846 NIM-ECLIPSE® CONTROLLER STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. ECLC 211278109 00643169378469

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention