BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTIV

    MDR report key: 25056287 · Received May 1, 2026

    Report

    Report Number
    3004209178-2026-07541
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    September 10, 2025
    Report Date
    May 1, 2026
    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
    PA, 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

    INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT REPORTED ISSUES WITH ADAPTIVESTIM SINCE DAY 1 OF DEVICE USE. PATIENT STATED WHEN LYING DOWN, STIMULATION DECREASED, BUT UPON STANDING SETTINGS DID NOT RETURN TO HIGHER LEVELS. PATIENT NOTED EVERY MORNING THEY HAD TO TURN THE DEVICE OFF AND ON TO REACH PREFERRED SETTINGS. PATIENT STATED STANDING DID NOT TRIGGER STAND-UP SETTINGS AND STIMULATION REMAINED AT LYING-DOWN LEVEL. PATIENT EMPHASIZED THERAPY WAS NOT AUTOMATIC AS EXPECTED. AGENT REVIEWED INFORMATION AND REDIRECTED THE PATIENT TO HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125800 INCEPTIV STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 977119 00763000540302

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male