BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM X

    MDR report key: 24630277 · Received March 18, 2026

    Report

    Report Number
    3004209178-2026-04876
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    March 12, 2026
    Report Date
    March 18, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00763000484668
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. 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 WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FORURGE INCONTINENCE, URINARY/BOWEL DYSFUNCTION IT WAS REPORTED THAT .THE PATIENT SAID THAT THEY ARE HAVING TROUBLE SETTING UP NEW EQUIPMENT AS THEY ONLY SEE A OPTION FOR NPP AND SOMETHING ELSE INSTEAD OF THE NPA FOR CONNECTING THE COMMUNICATOR. DURING THE CALL AGENT STARTED WALKING PATIENT THROUGH CONNECTING EQUIPMENT AND PATIENT REPORTED SEEING COMMUNICATOR CONNECTION LOST MESSAGE. PATIENT HAD COMMUNICATOR PLUGGED IN AND AGENT REVIEWED TO UNPLUG COMMUNICATOR AS COMMUNICATOR CAN'T CONNECT AND CHARGE AT THE SAME TIME. PATIENT STATED THE COMMUNICATOR BATTERY WAS TOO LOW, PATIENT UNPLUGGED COMMUNICATOR AND SAW A MESSAGE THAT COMMUNICATOR BATTERY WAS LOW. AGENT STARTED TO REVIEW THIS COULD BE WHY THINGS WERE NOT CONNECTING, THE PATIENT CALLED BACK WITH EXTERNAL EQUIPMENT FOR ASSISTANCE PAIRING. AGENT WALKED PATIENT THROUGH ATTEMPTING TO PAIR HANDSET WITH COMMUNICATOR, THE COMMUNICATOR BLUE TOOTH LIGHT WAS SOLID INDICATING THAT THE HANDSET AND COMMUNICATOR WERE COMMUNICATING BUT THE PATIENT WOULD GET "NO DEVICE FOUND" AFTER TAPPING FIND DEVICE. NO COMMUNICATOR FOUND/SWITCH COMMUNICATOR DID NOT COME UP AS AN OPTION. THE COMMUNICATOR WAS RIGHT OVER IMPLANY, RETRYING DID NOT RESOLVE. THE PATIENT SAID THEY HAD STOPPED FEELING STIMULATION ABOUT THREE DAYS AGO AND HAD A SUDDEN RETURN OF SYPTOMS AROUND THE SAME TIME. PATIENT SAID THEIR SYMPTOMS WERE BACK TO WHERE THEY USED TO BE BEFORE THEY GOT THE DEVICE. AGENT REVIEWED THE POSSIBILITY OF IMPLANT BEING AT END OF SERVICE. AGENT REDIRECTED PATIENT TO HEALTH CARE PROVIDER. (HCP) CALLER WILL FOLLOW UP WITH HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689368 INTERSTIM X STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 97800 00763000484668

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female