BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTIV

    MDR report key: 23758094 · Received December 9, 2025

    Report

    Report Number
    3004209178-2025-20753
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    December 6, 2025
    Report Date
    January 5, 2026
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B5 UPDATED. 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.

    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 REP CALLED BACK IN AND STATED THAT THEY HAD RECEIVED THEIR COMMUNICATOR AND WANTED TO CONNECT IT TO IMPLANT. AGENT HAD PATIENT TURN ON THE COMMUNICATOR, BUT IT WOULD BLINK YELLOW AND WOULD TURN OFF. AGENT INSTRUCTED CALLER TO CHARGE THE COMMUNICATOR. PATIENT WILL CALL BACK FOR FURTHER ASSISTANCE.PATIENT REP CALLED BACK FOR ASSISTANCE WITH PAIRING THE NEW COMMUNICATOR, HOWEVER THEY KEPT SEEING NO DEVICE FOUND. AGENT ASKED THE CALLER IF THE IMPLANT WAS CHARGED AND CALLER SAID NO. AGENT REVIEWED WITH THE CALLER TO CHARGE THE IMPLANT AND THEN CALL BACK FOR ASSISTANCE WITH PAIRING THE NEW COMMUNICATOR. CALLER WAS UPSET AND FRUSTRATED DURING THE CALL.PATIENT REP CALLED BACK FOR ASSISTANCE WITH PAIRING THE COMMUNICATOR SINCE EVERYTHING WAS CHARGED NOW.AGENT REVIEWED AND STARTED GUIDING THE CALLER THROUGH THE PAIRING, HOWEVER CALLER SAW NO DEVICE FOUND. AGENT REVIEWED. AGENT HAD THE CALLER REPOSITION THE COMMUNICATOR OVER THE IMPLANT. CALLER WAS BEING RUDE AND BECOMING ESCALATED AGAIN. AGENT ASKED THE CALLER IF THE IMPLANT WAS FUR SURE CHAR GED. CALLER SAID THAT THEY CHARGED THE IMPLANT LAST NIGHT TO 100%. AGENT HAD THE CALLER INITIATE AN IMPLANT RECHARGING SESSION. CALLER WAS VERY CONFUSED ON USING THE EQUIPMENT DURING THE CALL AGAIN. CALLER SAW EXCELLENT CONNECTION AND THE IMPLANT BATTERY WAS EMPTY. AGENT REVIEWED TO CHARGE THE IMPLANT AND THEN FINISH PAIRING THE COMMUNICATOR. CALLER SAID THAT THE EQUIPMENT WAS NOT WORKING. AGENT REVIEWED THAT THE EQUIPMENT WAS WORKING AND THAT THE IMPLANT JUST NEEDED TO BE CHARGED AGAIN. CALLER SAID THAT THE IMPLANT SHOULDN'T HAVE DRAINED IN 24 HOURS. AGENT REVIEWED THAT IMPLANT BATTERY DEPLETION WAS BASED ON THERAPY SETTINGS/USAGE AND REDIRECTED TO HCP.CALLER CALLED BACK STATING THEY RECEIVED A NEW COMMUNICATOR BUT THE PATIENT DEVICE WAS NOT TALKING TO ONE ANOTHER FOR IT WAS SAYING NOT CONNECTED. CALLER SAID EVERYTHING WAS CHARGED; THE PATIENT IMPLANT, COMMUNICATOR AND WIRELESS RECHARGER WAS CHARGED. CALLER WAS TRYING TO GET THE COMMUNICATOR TO COMMUNICATE TO THE WIRELESS RECHARGER BUT THE WIRELESS RECHARGER WOULD NOT TALK TO THE COMMUNICATOR. AGENT ASKED FURTHER CLARIFICATION TO UNDERSTAND SITUATION BUT CALLED GOT ESCALATED AND WAS YELLING. CALLER SAID THEY WERE NOT SURE WHAT THEY WERE DOING. DURING CALL CALLER OPENED THE HANDSET AND WAS IN THE RECHARGER APPLICATION. CALLER RESET THE COMMUNICATOR AND CLOSED ALL APPLICATIONS. CALLER WAS GETTING NOT FOUND, THE WIRELESS RECHARGER WAS TURNED ON; CALLER TURNED OFF WIRELESS RECHARGER. CALLER CLOSED ALL APPLICATIONS AGAIN, RESET HANDSET, AND RESET COMMUNICATOR. CALLER ENTERED COMMUNICATOR SERIAL NUMBER AND WAS ABLE TO CONNECT TO THERAPY APPLICATION. AGENT CLOSED CASE.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM PATIENT'S REP REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS CALLER REPORTED THAT THEY WERE HAVING ISSUES CONNECTING THE COMMUNICATOR TO THE INS. AGENT HAD CALLER RESET THE COMMUNICATOR AND WALKED CALLER THROUGH ACCESSING MYSTIM. CALLER CONFIRMED SET UP LINK SCREEN APPEARED, BUT PATIENT WAS NOT AVAILABLE AT THE TIME OF THE CALL. CALLER WILL CALL BACK WITH THE PATIENT FOR FURTHER TROUBLESHOOTING. AGENT CALLED CALLER BACK TO TROUBLESHOOT THE DEVICE. AGENT HAD CALLER RESET THE COMMUNICATOR AND WALKED CALLER THROUGH ACCESSING MYSTIM BUT "NO DEVICE FOUND" MESSAGE APPEARED. PATIENT CONFIRMED BLUETOOTH AND LOCATION WAS ON. AGENT HAD PATIENT RESET THE HANDSET AND COMMUNICATOR AND ACCESS THE MYSTIM AGAIN BUT "NO DEVICE FOUND" DISPLAYED AGAIN. THE ISSUE WAS NOT RESOLVED. AGENT SENT A REQUEST TO REPAIR TO REPLACE THE COMMUNICATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2603803 INCEPTIV STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 977119 00763000540302

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female