BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM¿

    MDR report key: 24632615 · Received March 18, 2026

    Report

    Report Number
    3004209178-2026-04844
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    January 5, 2024
    Report Date
    March 18, 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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 HEALTHCARE PROVIDER REGARDING 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 WERE NEEDING BRAIN MRI. THE HEALTHCARE PROVIDER (HCP) THAT THEY ASSUME THAT THE PATIENT (PT) WAS REFERRING TO THE INS NOT WORKING. CALLER THEN SPOKE WITH PT'S NURSE WHO STATED THAT THE PT HAD AN MRI A WHILE BACK AND THE INS WAS PUT INTO MRI MODE BEFOREHAND HOWEVER ONCE THEY PT GOT BACK HOME THEY COULDN'T GET THE INS OUT OF MRI MODE. HCP SUSPECTS THIS HAPPENED ON (B)(6) 2024 WHEN PT HAD A CERVICAL MRI DONE. AGENT SUGGESTED TROUBLESHOOTING WITH EXTERNAL EQUIPMENT, REVIEWED MRI COMPATIBILITY INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695052 INTERSTIM¿ STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male