BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 22100528 · Received May 28, 2025

    Report

    Report Number
    2182207-2025-01422
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Report Date
    May 28, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Removal / Correction Number
    Z-0294-2022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: WR9200, SERIAL# (B)(6), PRODUCT TYPE RECHARGER. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: WR9200, SERIAL/LOT #: (B)(6), G2: THE COUNTRY OF ORIGIN IS SOUTH KOREA. H3: THE WIRELESS RECHARGER, MODEL# WR9200, SERIAL# (B)(6), WAS RETURNED FOR PRODUCT ANALYSIS. ANALYSIS FOUND THAT THE RECHARGER WAS UNRESPONSIVE; LED'S SCROLLED CONTINUOUSLY. FLASH SECTOR READ/WRITE PROTECTION BITS HAD BECOME SET. NO ANOMALIES WERE VISUALLY OBSERVED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WIRELESS RECHARGER KEPT MALFUNCTIONING; THERE WAS POOR CONTACT. NO FURTHER EVENT INFORMATION WAS KNOWN. THE DEVICE WAS RETURNED FOR REPAIR. NO SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851312 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

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