BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTIV

    MDR report key: 23415547 · Received October 29, 2025

    Report

    Report Number
    3004209178-2025-18439
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    October 27, 2025
    Report Date
    October 29, 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
    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'S (PT) REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS).  THE REASON FOR CALL WAS CALLER STATING THAT YESTERDAY, THEY HAD A REP REPROGRAM THE BACK STIMULATOR. WHEN THE PT GOT HOME, THEY LAID DOWN IN AN ADJUSTABLE BED AND WENT DOWN AND COULD FEEL THE STIMULATOR VIBRATING. CALLER STATED THEY TRIED TO 'CONNECT TO THE REMOTE' BUT IT KEEPS ASKING FOR THE SERIAL AND THEIR 'CONNECTOR' IS NRA NOT NPE. AGENT COULD HEAR THE RECHARGER BEEPING. AGENT REVIEWED DEVICE FUNCTION AND BEST PRACTICES FOR EXTERNAL DEVICES. AGENT HAD CALLER CLOSE ALL APPS AND RESET THE COMMUNICATOR. AFTER ENTERING THE COMMUNICATOR SERIAL NUMBER, PT WAS THEN ABLE TO ENTER INTO MY STIM APPLICATION WITHOUT ISSUE. THE TROUBLESHOOTING STEPS TAKEN ON THE CALL RESOLVED THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219360 INCEPTIV STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 977119 00763000540302

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female