BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTIV

    MDR report key: 22776713 · Received August 11, 2025

    Report

    Report Number
    3004209178-2025-13591
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    August 4, 2025
    Report Date
    August 11, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000540302
    PMA / PMN Number
    P840001
    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 PATIENT'S REP REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS CALLER REPORTED THAT THE PATIENT WAS EXPERIENCING SO MUCH PAIN AFTER THEIR ADJUSTMENT. CALLER STATED THAT THE PATIENT HAD ADJUSTMENT ON MONDAY, AND THEY PUT HIM ON THE TYPE OF PROGRAM WHERE THERE WAS A CAP ON THE STIMULATION WHERE IT CAN SENSE EVERYTHING, AND THEY ONLY NEED TO CHARGE THE INS ONCE A WEEK INSTEAD OF EVERY DAY. CALLER STATED THE PERSON THAT DID THE ADJUSTMENT FOR THE PATIENT GOT IT ALL SET, AND THEY WANTED THEM TO BE ON IT FOR 2 WEEKS, BUT THE PATIENT WAS NOW IN SO MUCH PAIN. CALLER STATED THAT WHEN THEY INCREASED THE INTENSITY, THE PATIENT WOULD GET A "ZING" FROM THE STIMULATOR, SO THE MANUFACTURER REPRESENTATIVE (REP) SET IT TO 4.0, BUT WHEN THE PATIENT MOVED A LITTLE BIT, THEY WOULD GET A "ZING" ON THEIR SIDE, SO THE REP SET IT TO 3.8, AND IT SEEMED THAT THE PATIENT WAS FINE FOR A LITTLE BIT. CALLER THEN STATED THAT WHEN NIGHT COMES IT GETS WORSE AND WHEN THE PATIENT WAKES UP IN THE MORNING THEY LOOK MISERABLE AND N EED TO TAKE PAIN MEDICINE, BUT THAT CONSTIPATES THE PATIENT. CALLER STATED THAT THE PATIENT DID BETTER ON OTHER PROGRAMS, BUT THEY WANTED PROGRAM D TO WORK. CALLER ALSO STATED THAT THEY DON'T WANT TO CHANGE THE PROGRAM AS THE REP WANTS THEM TO USE PROGRAM D FOR 2 WEEKS. AGENT REDIRECTED THE CALLER TO HEALTHCARE PROVIDER (HCP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2109109 INCEPTIV STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 977119 00763000540302

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male