BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 INTERFACE

    MDR report key: 6054912 · Received October 25, 2016

    Report

    Report Number
    1045254-2016-00359
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    September 29, 2016
    Report Date
    September 30, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 8253001: MAINFRAME NIM RESPONSE 3.0, SERIAL # (B)(4), LOT # 65272000, MANUFACTURED DATE -DEC/14/2009, 510(K) # K083124. THE NIM PATIENT INTERFACE (PART # 8253200) WAS AND THE NIM MAINFRAME (PART # 8253001) WERE RETURNED FOR EVALUATION. EVALUATION OF PATIENT INTERFACE (PART # 8253200) COULD NOT DUPLICATE CUSTOMER'S ISSUE OF INTERMITTENT BOARD FAILURE. HOWEVER THE UNIT STIM 1 WAS NOT WORKING DUE TO A BLOWN FUSE. THE WAVE WASHER WAS REPLACED DUE TO A LOOSE CLIP. THE DEVICE WAS REPAIRED, TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. EVALUATION OF THE NIM MAINFRAME (PART # 8253001) COULD NOT DUPLICATE CUSTOMER'S ISSUE OF INTERMITTENT BOARD FAILURE. AS A PRECAUTIONARY MEASURE THE DEVICE WAS PLACED IN THE BURN IN FOR 24 HOURS ATTEMPTING TO OBSERVE ANY HEAT FAILURES. THE DEVICE DID NOT FAIL. EVALUATION FOUND NO FAULT WITH THE DEVICE. THE DEVICE TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTRA-OPERATIVE THE SYSTEM HAD AN INTERMITTENT BOARD FAILURE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THE SYSTEM PROVIDED NO ALERT OF THE ISSUE. THE DEVICE WAS INITIALLY FUNCTIONING DURING THE CASE, THEN IT WAS INTERMITTENT. AT ONE POINT DURING THE SURGERY, THE DOCTOR VISUALIZED A NERVE, THERE WAS NO RESPONSE FROM THE SYSTEM. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707072 NIM® 3.0 INTERFACE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253200 207847324

    Patients

    Seq Age Sex Outcome Treatment
    1