BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® STIMULATING PRASS TIP PROBE

    MDR report key: 4711277 · Received April 21, 2015

    Report

    Report Number
    1045254-2015-00129
    Event Type
    Malfunction
    Date Received
    April 21, 2015
    Date of Event
    March 23, 2015
    Report Date
    March 26, 2015
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: MAINFRAME 8253001 NIM RESPONSE 3.0, 510K: (B)(4), SERIAL # (B)(4), LOT# 206349767, MFR DATE: 2012-11-19. PATIENT INTERFACE 8253200 RESPONSE 3.0, 510K: (B)(4), SERIAL # (B)(4), LOT# 206441640, MFR DATE: 2012-12-11. (B)(4). THE STIMULATING PRASS PROBE IN QUESTION WAS DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. HOWEVER, THE CONCOMITANT DEVICES WERE RETURNED. THE PRODUCT ANALYSIS FOR THE NIM RESPONSE 3.0 MAINFRAME 8253001 STATES THAT THE UNIT WAS EXAMINED AND THE CUSTOMER¿S ISSUE COULD NOT BE DUPLICATED. AS A PREVENTIVE MAINTENANCE MEASURE, THE SOFTWARE WAS UPDATED TO THE MOST RECENT VERSION. DURING THE SOFTWARE UPDATE, THE DSP BOARD AND CF CARD FAILED, AS A STRANGE BEEPING SOUND WAS HEARD. THESE PARTS WERE REPLACED, AND THE SOFTWARE UPGRADE WAS SUCCESSFUL. THERE WERE NO OTHER ISSUES WITH THE DEVICE. THE PRODUCT ANALYSIS FOR THE NIM RESPONSE 3.0 PATIENT INTERFACE INDICATES THAT NO ISSUES WERE FOUND ASIDE FROM WORN WAVE WASHERS. THE DEVICE OTHERWISE MET MANUFACTURER SPECIFICATIONS.

    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 THAT ¿THE NURSE EXPERIENCED AN ISSUE WITH THE PRASS PROBE NOT WORKING WELL WHEN USED WITH THE NIM.¿ THE NURSE REPORTED THAT SHE CHECKED CONNECTIONS AND EVERYTHING APPEARED TO BE CONNECTED CORRECTLY. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263880 NIM® STIMULATING PRASS TIP PROBE STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC XOM UNKNOWN NIM

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR