BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LGW

    MDR report key: 22126915 · Received June 2, 2025

    Report

    Report Number
    3004209178-2025-09381
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    May 28, 2025
    Report Date
    June 2, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000558826
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) EXPERIENCED A BAD FALL. FOLLOWING THE FALL, THE PATIENT REPORTED A LOSS OF SPINAL CORD STIMULATOR SENSATION ON THE LEFT SIDE AND RECEIVED PROGRAMMER MESSAGES THAT PREVENTED AN INCREASE IN STIMULATION. UPON EVALUATION, MINIMAL SPINAL CORD STIMULATOR COVERAGE WAS NOTED ON THE LEFT SIDE AFTER REPROGRAMMING, WHILE GOOD COVERAGE PERSISTED ON THE RIGHT SIDE. AN IMPEDANCE CHECK REVEALED THAT ELECTRODES 2, 3, 4, 5, AND 6 WERE OUT OF RANGE. IT WAS REPORTED THAT THE CAUSE OF THE ISSUE WAS THE PATIENT'S FALL. REPROGRAMMING WAS PERFORMED AS A TROUBLESHOOTING STEP, AND THE PATIENT WAS ADVISED TO TRY THE NEW PROGRAMMING AND REPORT BACK TO THE HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718409 LGW STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 977118 00763000558826

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male