BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INTERFACE NIM4CPB1 NIM 4.0

    MDR report key: 21879040 · Received April 22, 2025

    Report

    Report Number
    1045254-2025-01164
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    February 19, 2025
    Report Date
    April 22, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00763000395902
    PMA / PMN Number
    K200759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS FOUND THAT THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED, NO FAULT WITH HARD WIRED. SOFTWARE WAS UPDATED AND REPLACED BAD FUSE. 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), UDI#: (B)(4). H3: PRODUCT ANALYSIS FOUND THAT THE CUSTOMER COMPLAINT WAS CONFIRMED, PMB AND EIE BOARD FAILURE. SOFTWARE WAS UPDATED TO V1.7.5. 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 DURING PRE-OP THAT REOCCURRING CONNECTION ISSUES WITH PI BOX WHEN WIRED (PI BOX DOES NOT RECOGNIZE CABLE). UNUSUAL NOISE AND ERRORS WHEN BOOTING UP, "SELF TEST FAILED", AND DURING USE, OUT OF MEASUREMENT RANGE - CALIBRATING, WHEN NOT USING CAUTERY. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338461 PATIENT INTERFACE NIM4CPB1 NIM 4.0 STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. NIM4CPB1 00763000395902

    Patients

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