BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM¿

    MDR report key: 24085469 · Received January 15, 2026

    Report

    Report Number
    3004209178-2026-00761
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    December 25, 2025
    Report Date
    January 27, 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
    GA, 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

    G4: CORRECTION SUBMITTED TO UPDATE PMA TO P970004. 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 DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THEY FELL INTO A HOLE AND LANDED PRETTY HARD RIGHT ON THE INS. THE PATIENT STATED THAT THEY WERE IN EXTREME PAIN AND HAD SYMPTOMS, AND THEY FELT LIKE SOMETHING WASN'T RIGHT WITH THE INS. THE PATIENT WAS EXAMINED IN THE ER BUT THE ER STAFF COULD NOT EXAMINE THE INS. THE PATIENT HAD NOT CONNECTED "TO THE" INS TO CHANGE SETTINGS OR TURN IT OFF, AND THEY DID NOT HAVE THE HANDSET WITH THEM AT THE TIME OF THE CALL. THE PATIENT WAS AT THEIR (B)(6) BEACH HOME AT THE TIME OF THE CALL, BUT THEIR HANDSET WAS AT THEIR (B)(6) HOME. THE PATIENT DID NOT HAVE A MANAGING HEALTHCARE PROVIDER (HCP) AT THE TIME OF THE CALL AND REQUESTED LISTINGS OF HCPS NEAR (B)(6) BEACH WHO COULD DO AN EVALUATION OF THE INS. THE AGENT EMAILED THE PHYSICIAN LISTINGS AND REDIRECTED THE PATIENT TO AN HCP TO FURTHER ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147238 INTERSTIM¿ STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female