BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM VITAL¿ PATIENT INTERFACE 4 CHANNEL

    MDR report key: 20061993 · Received August 26, 2024

    Report

    Report Number
    1045254-2024-01330
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 18, 2024
    Report Date
    March 12, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K200759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NIM4CM01, SERIAL/LOT #: (B)(6)/223990199, UDI#: (B)(4). PRODUCT ANALYSIS (B)(4): THE INITIAL INSPECTION REVEALS THAT THE REPORTED ISSUE WAS CONFIRMED. THE CONNECTOR PART WAS DAMAGED. PATIENT INTERFACE (B)(4) IMDRF CODINGS: FDD A070803, FDM B01, FDR C070601, FDC D02 & IMG G04034. MANUFACTURING DATE FOR PLI-60 (CONSOLE) : 2022-03-16 CONSOLE (B)(4) IMDRF CODINGS: FDD A070803, FDM B21, FDR C21, FDC D16 &IMG G02030. 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: PATIENT INTERFACE (NIM4CPB1) COULD NOT VERIFY THE NO POWER. THE CONNECTOR PART WAS DAMAGED AND DEFECTIVE FUSE LABEL. H6: INITIALLY SUBMITTED CODES FDR C070601 & FDC D02 ARE NO LONGER APPLICABLE. PRODUCT ANALYSIS: NIM CONSOLE (NIM4CM01) COULD NOT VERIFY NO POWER. THE UNIT PRESENTED WITH A SOFTWARE (V1.1.1) FAILURE DUE TO A DEFECTIVE SSD. H6: INITIALLY SUBMITTED CODES FDM B21, FDR C21, FDC D16 ARE NO LONGER APPLICABLE.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

    H3: UPDATED PRODUCT ANALYSIS: PATIENT INTERFACE ((B)(6)): DURING THE INSPECTION UPON ACCEPTANCE, THE REQUESTED PHENOMENON WAS OBSERVED. ALSO, IT WAS OBSERVED THAT THE VERSION IS NOT THE LATEST. UPDATED PRODUCT ANALYSIS: NIM CONSOLE ((B)(6)) DURING THE INSPECTION UPON ACCEPTANCE, THE REQUESTED PHENOMENON WAS OBSERVED. ALSO, IT WAS OBSERVED THAT THE VERSION IS NOT THE LATEST. 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 PRE-OP, TRIED TO TURN IT ON TO UPGRADE THE NIM FCA VERSION, BUT THE DEVICE WOULD NOT START. THERE WAS A BEEPING SOUND DURING STARTUP, AND EVEN AFTER RESTARTING FIVE TIMES, THERE WAS NO IMPROVEMENT. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231962 NIM VITAL¿ PATIENT INTERFACE 4 CHANNEL STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. NIM4CPB1 223622934

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown "SEE H11...."