BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM X

    MDR report key: 23368456 · Received October 23, 2025

    Report

    Report Number
    3004209178-2025-18042
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    October 7, 2025
    Report Date
    October 23, 2025
    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
    FL, 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. 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 URINARY/BOWEL DYSFUNCTION AND URGE INCONTINENCE. IT WAS REPORTED THAT PATIENT STATES THEY FELL ON A CRUISE SHIP LAST TUESDAY AND SINCE THEN HAVING HAD NO CONTROL. PATIENT WENT TO THE ER ON THURSDAY AND THEY DID AN X RAY AND IT LOOKED LIKE EVERYTHING WAS STILL CONNECTED . THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. AGENT CALLED THE PATIENT BACK AND THEY CONFIRMED THERAPY IS ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2729759 INTERSTIM X STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 97800 00763000484668

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female