BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM-ECLIPSE® CONTROLLER

    MDR report key: 4310058 · Received December 9, 2014

    Report

    Report Number
    1045254-2014-00321
    Event Type
    Injury
    Date Received
    December 9, 2014
    Date of Event
    November 15, 2014
    Report Date
    November 15, 2014
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    GWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT DEVICES: COMPUTER NCCPU-IT NOTEBOOK (B)(4), 510K: K061639 , SERIAL # (B)(4), LOT# 205727881, MANUFACTURE DATE: 2012-02-23, MODULE OPM660, PATIENT- 510 (K) - K050798, SERIAL # (B)(4), LOT# 1699788, MANUFACTURE DATE: 2011-05-12, ELECTRODE MEP1001 KEYED CORKSCREW- 510(K) - K050194, LOT# 140117009, MANUFACTURE DATE: 2014-03-24, EXPIRATION DATE: 2017-01-16, ELECTRODE NRE1003 SD NEEDLE RECORDING- 510(K) - K850108, LOT# 140117009, EXPIRATION DATE: 2016-10-16. PMA 510(K). DEVICE NOT CLEARED IN US, BUT SIMILAR DEVICE IS AVAILABLE. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. METHOD: NO TESTING METHODS PERFORMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, ¿ON (B)(6) 2014, DR (B)(6) USED THE NIM ECLIPSE SD SYSTEM (EC LC+OPM660+NCCPU-IT) TO MONITOR THE MEP IN A CASE OF SCOLIOSIS. THE DAY AFTER (B)(6) THE SURGERY, THE CUSTOMER INFORMS THAT THE PATIENT WAKES UP FROM THE SURGERY WITH MUSCLES ISSUES ON BOTH LEGS. DURING THE SURGERY THE SYSTEM WORKS PROPERLY.¿ THE PATIENT HAD AN ADDITIONAL PROCEDURE TO REDUCE THE COMPLICATION AND IS UNDERGOING THERAPY. SHE HAS MOVEMENT IN BOTH LEGS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795138 NIM-ECLIPSE® CONTROLLER STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED, INC ECLC 205740236

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention