BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM-ECLIPSE® PATIENT MODULE

    MDR report key: 7143753 · Received December 22, 2017

    Report

    Report Number
    1045254-2017-00489
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    November 7, 2017
    Report Date
    February 7, 2018
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00613994870810
    PMA / PMN Number
    K061639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE OPM660 PATIENT MODULE WAS RECEIVED IN SERVICE AND REPAIR. THE CUSTOMER¿S COMPLAINT HAS BEEN CONFIRMED; THE DEVICE HAD A PATIENT INTERFACE MODULE COMMUNICATION ERROR. THE CONTROL PWA AND THE ELECTRODES PWA (PRINTED WIRING ASSEMBLY/PCB) HAVE BEEN REPLACED. THE DEVICE HAS BEEN SUCCESSFULLY TESTED ACCORDING TO SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: ANALYSIS RESULTS ARE NOT AVAILABLE; DEVICE NOT RETURNED FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT DURING A LUMBAR FUSION FOR SCOLIOSIS THE SIGNAL ON THE NIM SYSTEM WAS LOST, THE PATIENT MODULE WAS OUT OF ORDER. THE SURGEON HAD ALREADY DISSECTED DOWN TO THE SPINAL CORD AND PLACED THE SCREWS WHEN ALL 8 CHANNELS, 4 LEFT AND 4 RIGHT, LOST CONNECTION. THE SYSTEM CONNECTIONS WERE DISCONNECTED AND CONNECTED MANY TIMES TO TRY AND REGAIN THE CONNECTION, WITH NO RESOLVE. THE SURGEON DECIDED TO STOP THE PROCEDURE BECAUSE OF A RISK OF SPINAL CORD INJURY DURING THE REDUCTION OF THE SCOLIOSIS. THE PROCEDURE WAS RESCHEDULED AND SUCCESSFULLY COMPLETED 3 DAYS LATER WITH A BACKUP PATIENT MODULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921026 NIM-ECLIPSE® PATIENT MODULE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. OPM660 212385346 00613994870810

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention