BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPUTER NOTEBOOK (INTERNATIONAL)

    MDR report key: 24859098 · Received April 13, 2026

    Report

    Report Number
    3005677016-2026-00005
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    March 16, 2026
    Report Date
    May 28, 2026
    Manufacturer
    MEDTRONIC (CHANGZHOU) MEDICAL DEVICES
    Product Code
    GWF
    UDI-DI
    00199150028207
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS PRODUCT IS NOT MARKETED IN US BUT SIMILAR DEVICE WITH PRODUCT NUMBER (B)(4). WITH 510(K)# K061639 IS MARKETED IN US. 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 #(B)(4): PRODUCT:MCEQ2020, S/N:(B)(6). ANALYSIS CONFIRMED THAT NO ABNORMALITIES WERE FOUND AS A RESULT OF THE INSPECTION. 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

    INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS AN INSTANCE WHERE THE A SOUND INDICATING POWER BEING SUPPLIED DID NOT OCCUR IN TRIGGER EMG. THE SEQUENCE WAS SET (INTERVALS OF 10 SECONDS) IN ABR, BUT THE TEST DID NOT RESUME EVEN WHEN THE COUNT BECAME "ZERO". THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT EVEN AT THE TIMING WHEN THE MEASURED CURRENT VALUE CHANGED FROM ¿ZERO¿ TO THE ACTUAL VALUE, THERE WAS NO SOUND (RESPONSE). THE FUNCTION THAT FELT ABNORMAL WAS NOT AN ESSENTIAL ONE, BUT RATHER A ¿CONVENIENT FEATURE,¿ SO THE EXAMINATION COULD BE CONDUCTED WITHOUT ANY ISSUES EVEN WITHOUT THIS FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224067 COMPUTER NOTEBOOK (INTERNATIONAL) STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC (CHANGZHOU) MEDICAL DEVICES MCEQ2020 00199150028207

    Patients

    Seq Age Sex Outcome Treatment
    1