BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® 3.0 MAINFRAME INTERNATIONAL

    MDR report key: 6677701 · Received June 29, 2017

    Report

    Report Number
    1045254-2017-00212
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    April 18, 2017
    Report Date
    November 21, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00643169230392
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: MAINFRAME 8253002 NIM RESPONSE 3.0: THE DEVICE WAS RECEIVED IN SERVICE AND REPAIR. IT WAS TESTED WITH A PATIENT INTERFACE AND THE POWER CORD WAS PULLED OUT SEVERAL TIMES. IN EVERY CASE THE DEVICE MADE THE POWER OFF ALARM AS IT IS SUPPOSED TO DO (BEEPING SOUND). THE DEVICE FUNCTIONED PER SPECIFICATIONS, HOWEVER; THE SOFTWARE WAS UPDATED, AND THE DEVICE SUCCESSFULLY TESTED TO SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: ANALYSIS RESULTS ARE NOT AVAILABLE; DEVICE NOT RETURNED FOR EVALUATION. 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

    A REPORT FROM THE USER FACILITY STATES: ¿THE PATIENT NERVE SIMULATOR/MONITOR NIM RESPONSE 3.0 WAS IN USE AT (B)(6) HOSPITAL, SPECIAL THEATRES. THE MAINS LEAD WAS PULLED FROM THE UNIT; STAFF DID NOT HEAR THE MAINS FAILURE ALARM. THE SURGEON WAS NOT AWARE THE UNIT WAS NOT POWERED AND CONTINUED WITH THE PROCEDURE. THE SURGEON BECAME AWARE THE UNIT WAS NOT POWERED PART WAY THROUGH THE SURGICAL PROCEDURE, HOWEVER THE PATIENT HAS RECEIVED A DEGREE OF NERVE DAMAGE REQUIRING FURTHER MEDICAL INTERVENTION.¿ ATTEMPTS MADE FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED: IT WAS CONFIRMED THAT THE "MAINS LEAD" IS THE POWER CORD AND THE CORD THAT WAS IN USE WAS THE ONE INCLUDED WITH THE MAINFRAME UPON PURCHASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457967 NIM® 3.0 MAINFRAME INTERNATIONAL STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253002 208496285 00643169230392

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention