BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTIV

    MDR report key: 23453275 · Received November 3, 2025

    Report

    Report Number
    3004209178-2025-18711
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    May 7, 2025
    Report Date
    December 1, 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
    TX, US
    Reporter Occupation
    003

    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.

    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

    PATIENT REPORTED THAT THE NEW BATTERY WAS PUT IN "MYSTIM". PATIENT'S KEG STARTED HURTING, LIKE A NERVE ISSUE. BECAUSE OF PATIENT'S BAD EXPERIENCE WITH A REP, THEY HAD TO TRY SOMETHING SO THEY TURNED UP THE STIM. THE MORE THEY TURNED UP THE WORSE THEIR LEG HURT SO THE PATIENT STARTED TURNING IT DOWN GRADUALLY. THEY FOUND THEIR LEG DIDN'T HURT AS BAD. IT STILL HURTS BUT IS MUCH BETTER THAN IT WAS.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) . PT STATED THAT THEY CAN'T GET PAST TO 3 DAYS AND THEY HAD TO RECHARGE IT. PATIENT COMPARED IT TO THEIR OLD BATTERY THAT LAST FOR A WEEK AND A HALF BEFORE THEY RECHARGE. AGENT REVIEWED INFORMATION ON THE CHARGING FREQUENCY. PATIENT EXPRESSED FRUSTRATION STATED THAT IT WASA PAIN TO KEEP TRACK ON THE BATTERY BECAUSE IF THEY DO NOT RECHARGE THEY START TO FEEL HURT. AGENT REDIRECTED TO THEIR HCP TO GET IN CONTACT WITH A MANUFACTURER REPRESENTATIVE (REP). THE PATIENT (PT) REITERATED THAT WHEN THEY RECEIVED THEIR ¿NEW BATTERY¿ THEY THOUGHT THEIR CHARGE SHOULD LAST LONGER THAN THEIR PREVIOUS IMPLANT BUT THEY HAVE TO RECHARGE EVERY THREE DAYS AND STATE ¿THAT¿S CRAZY¿. THE PT ALSO REPORTS LEFT LEG PAIN THAT BEGAN AFTER THE BATTERY WAS PUT IN. PT REPORTS THE DEVICE TREATS THEIR RIGHT LEG PAIN WELL AND WAS NOT INITIALLY PROGRAMED TO TREAT LEFT LEG PAIN. PT DESCRIBES THEIR NEW PAIN AS IN THE GROIN OF THEIR LEFT LEG GOING DOWN, AND THEIR LEFT LEG WOULD ALMOST BUCKLE DUE TO THE PAIN. PT STATES THEY THOUGHT STIMULATION WAS UP TOO HIGH AND WAS CREATING LEG PAIN. PT REPORTS THEIR LEFT LEG PAIN IMPROVED WHEN THEY REDUCED THE INTENSITY. PT REPORTS ATTEMPTING TO HAVE AN APPOINTMENT WITH THEIR MANUFACTURER REPRESENTATIVE (REP) FOR REPROGRAMMING, BUT THEIR REP NEVER SHOWED UP. PT REPORTS THEY ¿MAY JUST LET THE BATTERY DIE¿ AS OPPOSED TO WORKING WITH THEIR REP. AGENT OFFERED TO TRANSFER PT TO PATIENT AND TECHNICAL SERVICES (PATS), PT DECLINED AND STATES "I FIGURE I'M ABOUT THE BEST I'M GOING TO GET". PT REPORTS NO TROUBLESHOOTING ACTIONS ARE PLANNED FOR THESE ISSUES. AGENT SENT E-MAIL TO REP/REP SUPERVISOR FOR VISIBILITY. PT PROVIDED THEIR E-MAIL FOR FURTHER COMMUNICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887099 INCEPTIV STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 977119 00763000540302

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male