BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® 3.0 MAINFRAME INTERNATIONAL

    MDR report key: 7037929 · Received November 16, 2017

    Report

    Report Number
    1045254-2017-00410
    Event Type
    Injury
    Date Received
    November 16, 2017
    Report Date
    November 28, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00613994529053
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE: 8253200: PATIENT INTERFACE 8253200 RESPONSE 3.0, S/N (B)(4), LOT 208714533 MANUFACTURED: 2014/09/08 UDI: (B)(4). PRODUCT EVALUATION: -- MAINFRAME 8253002 NIM RESPONSE 3.0 INTL ¿ THE DEVICE WAS RECEIVED IN GOOD COSMETIC CONDITION. TWO RUBBER FOOT STOPPERS WERE MISSING, WHICH WOULD NOT HAVE AFFECTED THE FUNCTIONALITY OF THE DEVICE. THE FOOT STOPPERS WERE REPLACED AND THE DEVICE WAS PLACED IN A CLIMATE CHAMBER FOR 48 HOURS TO STRESS COMPONENTS; NO DEVIATIONS WERE FOUND. THE DEVICE WAS SUCCESSFULLY TESTED TO SPECIFICATIONS. PATIENT INTERFACE 8253200 RESPONSE 3.0 ¿ THE DEVICE WAS RECEIVED WITH A BENT CLIP, WHICH WOULD NOT HAVE AFFECTED FUNCTIONALITY OF THE DEVICE. THE CLIP WAS STRAIGHTENED AND THE DEVICE SUCCESSFULLY TESTED TO SPECIFICATIONS. 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

    THE FACILITY REQUESTED EVALUATION AND PREVENTIVE MAINTENANCE ON THEIR NIM; STATING THAT ¿APPARENTLY WHEN USING THE NIM THE PATIENT GOT HARMED (FACIAL PARALYSIS). CAN YOU PLEASE SEE IF IT IS BECAUSE OF MALFUNCTIONING OF THE NIM OR IF IT IS DUE TO THE USE OF THE NIM?¿ NO MALFUNCTION WAS ALLEGED AGAINST THE SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED; AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: THE PHYSICIAN WAS CONTACTED AND WAS ABLE TO CLARIFY THE EVENT. SHE STATED THAT WHEN THESE DEVICES WERE CALLED IN FOR EVALUATION, "THE HOSPITAL DID NOT UNDERSTAND PROPERLY. THE NIM WAS NOT PART OF THE PROBLEM. THE CHILD WHO WAS ON THE TABLE HAS A PARTICULAR ANATOMY AND THE SURGEON KNEW SHE WAS NEAR THE FACIAL NERVE AND WAS WARNED IT. LUCKILY THE CHILD SUFFERED A REVERSIBLE PARALYSIS AND NOW SHE IS FINE." FURTHER CLARIFICATION WAS RECEIVED, CONFIRMING THAT THERE WAS NO "GOOD BUR IN THE HOSPITAL; SHE WAS USING ONE TOO BIG", WHICH SHE KNEW WOULD HAVE AN IMPACT ON THE PATIENT'S NERVE. "THE PATIENT HAS RECOVERED COMPLETELY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817012 NIM® 3.0 MAINFRAME INTERNATIONAL STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253002 64481100 00613994529053

    Patients

    Seq Age Sex Outcome Treatment
    1 Other