BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM RESPONSE® 3.0 PATIENT INTERFACE

    MDR report key: 3950992 · Received July 22, 2014

    Report

    Report Number
    1045254-2014-00156
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT DEVICE: 8253001, MAINFRAME 8253001 NIM RESPONSE 3.0 1, SERIAL NUMBER: (B)(4), LOT: 208127682, MANUFACTURED: MARCH 11, 2014, K083124, ETN. (B)(4). PRODUCT EVALUATION: SERVICE AND REPAIR INSPECTED THE PATIENT INTERFACE; REPLACED BLOWN FUSES AND WORN WAVE WASHERS DUE TO CABLE CLIP LOOSE. THE ITEM WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. SERVICE AND REPAIR EXAMINED THE MAINFRAME, (B)(4), AND COULD NOT DUPLICATE CUSTOMER¿S ISSUE. AS A PRECAUTIONARY MEASURE, PLACED UNIT IN BURN-IN FOR 24 HOURS ATTEMPTING TO OBSERVE ANY HEAT RELATED FAILURE. UNIT NEVER FAILED. THE UNIT WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR STATED THAT THE DEVICE IS NOT STIMULATING. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427579 NIM RESPONSE® 3.0 PATIENT INTERFACE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253200 208128182

    Patients

    Seq Age Sex Outcome Treatment
    1