BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINFRAME 8253001 NIM RESPONSE 3.0

    MDR report key: 3673039 · Received March 11, 2014

    Report

    Report Number
    1045254-2014-00055
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    February 14, 2014
    Report Date
    February 14, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. PATIENT INTERFACE 8253200 RESPONSE 3.0, 510K: K083124, SERIAL # (B)(4), LOT# 206445286, MFR DATE: 2012-12-12 ENT NIM P/N UNKNOWN (STIMULATION PROBE), SERIAL # AND LOT# UNKNOWN. (B)(4). THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. METHOD: NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED STIM 1 AND STIM 2 WEREN'T STIMULATING. THE STIMULATION PROBE WOULD NOT RESPOND BEYOND .01 AMPS. THE USER STATED HE WAS RECEIVING NO RESPONSE ON THE SCREEN AND THERE WAS NO AUDIO. HE STATES THERE WAS A BASELINE AT THE BEGINNING OF THE CASE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145595 MAINFRAME 8253001 NIM RESPONSE 3.0 STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001 206443410

    Patients

    Seq Age Sex Outcome Treatment
    1