BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 MAINFRAME

    MDR report key: 5596901 · Received April 21, 2016

    Report

    Report Number
    1045254-2016-00118
    Event Type
    Malfunction
    Date Received
    April 21, 2016
    Report Date
    March 23, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PATIENT INTFC 8253200, RESPONSE 3.0 ROHS, 510K: K083124, SERIAL NUMBER (B)(4), LOT NUMBER 208841683, MANUFACTURED DATE: 2014-10-21. BOTH DEVICES WERE ANALYZED. NO ISSUES COULD BE FOUND WITH EITHER DEVICE. THE MAINFRAME'S SOFTWARE WAS UPGRADED TO THE MOST CURRENT VERSION PER ROUTINE PREVENTIVE MAINTENANCE STANDARDS, AND A LOOSE MOUNTING CLIP WAS REPAIRED ON THE PATIENT INTERFACE.A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING PROPERLY. NO OTHER INFORMATION COULD BE OBTAINED, INCLUDING NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249436 NIM® 3.0 MAINFRAME STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001 73835500

    Patients

    Seq Age Sex Outcome Treatment
    1