BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM 4.0 CONSOLE

    MDR report key: 19017307 · Received April 2, 2024

    Report

    Report Number
    1045254-2024-00464
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    February 21, 2024
    Report Date
    August 14, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00763000395896
    PMA / PMN Number
    K200759
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NIM4CPB1, SERIAL/LOT #:(B)(6), UDI#: (B)(4). H3: ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. H6: CODES APPLICABLE ARE FDM B21, FDR C21, FDC D16. ADDITIONAL CODES IMG G02005 IS APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDICAL SAFETY HAS REVIEWED THE INFORMATION. THE REPORTED EVENT AND IT'S REPORTED SEVERITY ARE KNOWN AND LABELED PER PRA 1834094-L AND INSTRUCTIONS FOR USE M987224A001REVEEN. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS FURTHER FOUND THAT THERE WAS GAP BETWEEN DISPLAY AND BEZEL ON THE LEFT SIDE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS FOUND VERIFIED INCONSISTENT READINGS. UNIT PRESENTED WITH A SOFTWARE FAILURE DUE TO A DEFECTIVE SSD CARD(V1.1.1). H6: PREVIOUSLY APPLIED CODES FDM B21, FDR C21, FDC D16 ARE NO LONGER APPLICABLE. ADDITIONAL CODES IMG G02030 IS NO LONGER APPLICABLE. CODES APPLICABLE ARE FDM B01, FDR C10, FDC D02 AND IMG G0200702. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NIM4CPB1, SERIAL (B)(6) , (B)(4) : PRODUCT ANALYSIS FOUND VERIFIED INCONSISTENT READINGS. UNIT PRESENTED WITH UPDATED SOFTWARE:(V1.4.3), A COMMON MODE REJECTION FA ILURE, AND A WIRELESS CONNECTION FAULT DUE TO A DEFECTIVE MAIN PCBA. H6: PREVIOUSLY APPLIED CODES FDM B21, FDR C21, FDC D16 ARE NO LONGER APPLICABLE. CODES APPLICABLE ARE FDM B01, FDR C0208, FDC D02. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    PREVIOUSLY APPLIED CODE FDC D02 HAS BEEN CORRECTED TO D1102. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6), UDI#: (B)(4). PREVIOUSLY APPLIED CODE FDC D02 HAS BEEN CORRECTED TO D1102. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A HEAD AND NECK SURGERY, THERE WAS NO RESPONSE FROM THE NIM AT ALL WHILE THE SURGEON WAS ON NERVE. THE THRESHOLD WAS SET TO 100. AS THEY CONTINUED TO DISSECT, THE SURGEON REALIZED THAT HE HAD CUT THE NERVE AND HAD TO DO A NERVE GRAFT. SPECULATED THAT THERE WERE ISSUES WITH THE BLUETOOTH AND NO NOISE OR TWEEDLE SOUNDS WERE BEING DELIVERED BY THE NIM. THE PATIENT INTERFACE BOX WAS STARTED WIRELESS AND LATER PLUGGED IT IN. THERE WAS A PROCEDURAL DELAY OF THIRTY MINUTES. THE PROCEDURE WAS COMPLETED USING THE REPORTED PRODUCT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED, THERE WAS NO IMPROVEMENT ONCE THEY PLUGGED THE PATIENT INTERFACE CABLE IN. THE STIMULUS WAS SET BETWEEN 0.8 TO 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665690 NIM 4.0 CONSOLE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. NIM4CM01 226992453 00763000395896

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other