BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 24456587 · Received February 26, 2026

    Report

    Report Number
    3004209178-2026-03452
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    February 15, 2026
    Report Date
    February 26, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR, URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE REASON FOR THE CALL WAS THE PATIENT REPORTED THAT ALL OF A SUDDEN FOR THE LAST 3-4 DAYS IT HAD BEEN ZINGING/SHOCKING THEM. THE CALLER DID NOT KNOW WHAT CAUSED THIS ISSUE BUT STATED THAT IT STARTED WHEN THEY WERE LEANING OVER AT THEIR FRIEND'S HOUSE ON SUNDAY AND FELT IT MORE THAN USUAL BECAUSE IT HAD BEEN LIKE A YEAR SINCE THEY FELT IT ZING LIKE THAT. THE PATIENT HAD NOT HAD ANY FALLS OR TRAUMAS. THE PATIENT WAS FEELING THE SHOCKING IN THEIR RIGHT LOWER BACK GOING DOWN THEIR LEG AND NOTED IT WAS LESS PAINFUL WHEN STANDING COMPARED TO SITTING. THE PATIENT LOST THEIR PROGRAMMER SO NO TROUBLESHOOTING WAS POSSIBLE. THE PATIENT INDICATED THEY HAD ALREADY MADE ATTEMPTS TO CONTACT THEIR IMPLANTING DOCTOR BUT WAS TOLD CONFLICTING INFORMATION ABOUT INSURANCE COVERAGE FOR THIS PHYSICIAN. THE PATIENT WILL ATTEMPT TO CONTACT THE PHYSICIAN AGAIN BUT PATIENT SERVICES ALSO SENT PHYSICIAN LISTINGS IN CASE THEY ARE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525288 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female