BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTIV

    MDR report key: 22468407 · Received July 10, 2025

    Report

    Report Number
    3004209178-2025-11730
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    May 21, 2025
    Report Date
    July 10, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000540302
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. 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

    THE REASON FOR CALL WAS PATIENT WAS ON GROUP C AND THEY WERE NOT GETTING THE SAME RESULTS AS THEY GOT ON THEIR TRIAL. PATIENT HAD A CONTINUOUS ZING GOING ON WHEN THEY MOVED A CERTAIN WAY AND IF THEY WENT HIGHER IN INTENSITY IT ZED THEM MORE. PATIENT NOTED THEY HAD NEUROPATHY IN THEIR FEET AND IT HELPED BUT STIMULATION THERAPY WAS NOT HELPING IN THEIR LOWER BACK AND THEY STILL COULD NOT STAND FOR A LONG PERIOD. AGENT REVIED THEY CAN TRY OTHER GROUPS AND IF THAT DID NOT HELP THEN THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774902 INCEPTIV STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 977119 00763000540302

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female