BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM X

    MDR report key: 25153418 · Received May 12, 2026

    Report

    Report Number
    3004209178-2026-08148
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 12, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00763000892067
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLAN TED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT DURING 2ND PHASE PROCEDURE, THERE WAS NO DIFFICULTY INSERTING THE LEAD IN THE NEUROMODULATOR. THE BLUE MARKINGS WERE CLEARLY VISIBLE AT EACH INTERVAL AND AT THE END OF THE CHANNEL. NEUROMODULATOR INTEGRATED AT THE OPENING. BUT WHEN SCREWING WITH THE TORQUE WRENCH, IT WAS IMPOSSIBLE TO GET THE SCREW TO TIGHTEN; THE SCREW JUST KEEPS SPINNING THEY CHANGED THE TORQUE WRENCH WITHOUT SUCCESS. DECISION TO CHANGE THE NEUROMODULATOR. NO CONSEQUENCES FOR THE PATIENT. NO CAUSE KNOWN. ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362149 INTERSTIM X STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 97800 00763000892067

    Patients

    Seq Age Sex Outcome Treatment
    1