BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINFRAME 8253002 NIM RESPONSE 3.0 INTL

    MDR report key: 3437926 · Received October 30, 2013

    Report

    Report Number
    1045254-2013-00555
    Event Type
    Malfunction
    Date Received
    October 30, 2013
    Report Date
    October 9, 2013
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER FOR EVALUATION. METHOD: NO TESTING METHODS PERFORMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, ¿NIM 3.0 MALFUNCTIONS.¿ NO INDICATION OF PATIENT INJURY, AND NO OTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558425 MAINFRAME 8253002 NIM RESPONSE 3.0 INTL STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC 8253002

    Patients

    Seq Age Sex Outcome Treatment
    1