BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 20538887 · Received October 25, 2024

    Report

    Report Number
    2182207-2024-04373
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Report Date
    October 25, 2024
    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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID WR9200, LOT#/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). H3. ANALYSIS FOUND THAT THE RECHARGER WAS UNRESPONSIVE AND THE LED'S SCROLL CONTINUOUSLY DEVICE IS UNRESPONSIVE. FLASH SECTOR READ/WRITE PROTECTION BITS HAVE BECOME SET. AD456980 WAS OPENED TO ADDRESS SIMILAR ISSUES. G2. FOREIGN: KOREA. 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 THE MACHINE KEEPS MALFUNCTIONING. NO SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972891 IMPLANTABLE NEUROSTIMULATOR Stimulator, spinal-cord, totally implanted for pain relief LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown