BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINFRAME 8252201 NIM-PULSE 2.0

    MDR report key: 2897641 · Received January 4, 2013

    Report

    Report Number
    1045254-2013-00014
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Report Date
    December 5, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE NIM 2.0 MAINFRAME WAS RECEIVED IN GOOD COSMETIC CONDITION. - NIM PULSE MAINFRAME PASSED SAFETY TEST ON INCOMING INSPECTION. - PCB'S HAVE BEEN CHECKED FOR BURNED COMPONENTS; NO DEVIATIONS FOUND. - FLATCABLE PUNCTURED. (NOT LIKELY TO BE RELATED TO CUSTOMER'S COMPLAINT). REPAIR DESCRIPTION: - FLATCABLE HAS BEEN REPLACED. - NO DEVIATIONS HAVE BEEN FOUND, CUSTOMERS COMPLAINT COULD NOT BE CONFIRMED. - THE NIM 2.0 PULSE MAINFRAME HAS BEEN SUCCESSFULLY TESTED ACCORDING SRI:8252001/8252401(IP-NONIP)8252201/RF/9450006. UPON COMPLETION OF THE DEVICE EVALUATION IT WAS DETERMINED THAT THERE WAS NO FAULT FOUND. THE ALLEGED COMPLAINT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED. NO FAILURE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAINFRAME DEVICE WAS GIVING STAFF ELECTRIC SHOCKS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4939 MAINFRAME 8252201 NIM-PULSE 2.0 STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8252201 38238600

    Patients

    Seq Age Sex Outcome Treatment
    1 DEVICE 8252210 NIM-PULSE 2.0 INTERFACE