BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 MAINFRAME

    MDR report key: 6125321 · Received November 23, 2016

    Report

    Report Number
    1045254-2016-00400
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Report Date
    November 1, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE MFR. REC: DEC/6/2016. DEVICE EVALUATION HAS BEEN COMPLETED FOR THE NIM MAINFRAME (PRODUCT # ¿ 8253001) AND NIM PATIENT INTERFACE (PRODUCT # - 8253200). ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT OF NO RESPONSE FROM THE NIM SYSTEM. ANALYSIS OF THE NIM MAINFRAME (PRODUCT # ¿ 8253001) COULD NOT CONFIRM THE REPORTED EVENT OF NO RESPONSE FROM THE SYSTEM. THERE WAS NO FAULT FOUND WITH THE DEVICE. AS A PRECAUTIONARY MEASURE THE DEVICE WAS PLACED IN BURN IN FOR 24 HOURS TO OBSERVE ANY HEAT RELATED FAILURES. THE UNIT NEVER FAILED AFTER BEING PLACED IN BURN IN. THE DEVICE WAS TESTED TO ALL MANUFACTURING PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. ANALYSIS OF THE NIM PATIENT INTERFACE (PRODUCT # - 8253200) COULD NOT CONFIRM THE REPORTED EVENT OF NO RESPONSE FROM THE SYSTEM. THERE WAS NO FAULT FOUND WITH THE DEVICE. THE DEVICE WAS TESTED TO ALL MANUFACTURING PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): (B)(4): PATIENT INTERFACE RESPONSE 3.0, SERIAL # (B)(4), LOT # 211797581, MANUFACTURED DATE ¿AUG/15/2016, 510(K) # K083124. THE PRODUCT WAS RETURNED FOR ANALYSIS. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. 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.

    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 INTRA-OPERATIVE WHILE USING THE NIM SYSTEM, THE DOCTOR VISUALIZED THAT HE WAS ON A NERVE AND THERE WAS NO RESPONSE FROM THE NIM SYSTEM. THERE WAS NO PATIENT IMPACT. THE SALES REP CHECKED THE SYSTEM AND INDICATED EVERYTHING ON THE SYSTEM WAS SET UP CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775605 NIM® 3.0 MAINFRAME STIMULATOR, NERVE GWF MEDTRONIC XOMED INC. 8253001 211799299

    Patients

    Seq Age Sex Outcome Treatment
    1