BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL PREAMPLIFIER

    MDR report key: 25131987 · Received May 9, 2026

    Report

    Report Number
    3005677016-2026-00012
    Event Type
    Malfunction
    Date Received
    May 9, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 9, 2026
    Manufacturer
    MEDTRONIC (CHANGZHOU) MEDICAL DEVICES
    Product Code
    GWF
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS # PRODUCT: MCEQ2010, S/N: (B)(6). ANALYSIS CONFIRMED THAT VISUAL CHECK PASSED AND ELECTRICAL TEST AND FUNCTIONAL TEST PASSED. NO FAULT FOUND. G4: THIS PRODUCT IS NOT MARKETED IN US BUT SIMILAR DEVICE WITH PRODUCT NUMBER DAQ916 WITH 510(K)# K050798 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.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DIGITAL PREAMPLIFIER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE THIRD CHANNEL WAS NOT FUNCTIONING. THERE WAS NO REACTION IN THE THIRD CHANNEL. REPORTED ISSUE WAS NOT RESOLVED AT HOSPITAL AND SO, REPORTED PRODUCT WAS SENT TO REPAIR CENTER FOR RESOLUTION. AFTER THE MAINTENANCE TEAM RECEIVED THE EQUIPMENT, THEY CONDUCTED AN INSPECTION AND FOUND NO SUCH FAULT. THE FAULT DID NOT RECUR AND THE EQUIPMENT PASSED THE FINAL TEST. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242731 DIGITAL PREAMPLIFIER STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC (CHANGZHOU) MEDICAL DEVICES MCEQ2010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown