BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 MAINFRAME INTERNATIONAL

    MDR report key: 9584468 · Received January 13, 2020

    Report

    Report Number
    1045254-2020-00038
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Report Date
    February 19, 2020
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00643169230392
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT.  A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8253200, SERIAL/LOT #: (B)(4)/211003699, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER: 8253002, SERIAL NUMBER: (B)(4). MODEL NUMBER: 8253200, SERIAL NUMBER: (B)(4). MODEL NUMBER: 8253002, SERIAL NUMBER: (B)(4) ANALYSIS FOUND THERE WERE NO ANOMALIES IN THE DEVICE. MODEL NUMBER: 8253200, SERIAL NUMBER: (B)(4), ANALYSIS FOUND THAT THE FUSE WAS MISSING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTH CARE PROVIDER (HCP) REPORTED THAT NERVE MONITORING DEVICES WERE NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47160 NIM® 3.0 MAINFRAME INTERNATIONAL STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253002 211102797 00643169230392

    Patients

    Seq Age Sex Outcome Treatment
    1