BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 22959358 · Received September 3, 2025

    Report

    Report Number
    2182207-2025-02286
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    December 10, 2024
    Report Date
    September 3, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    UDI-DI
    00763000596743
    PMA / PMN Number
    P970004
    Removal / Correction Number
    Z-0293-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID WR9220, SERIAL# (B)(6): PRODUCT TYPE RECHARGER. H3: ANALYSIS OF THE RETURNED WIRELESS RECHARGER (S/N: (B)(6)) REVEALED NO VISUAL ANOMALIES WITH THE RETURNED DEVICE. DEVICE ANALYSIS FOUND THAT THE DEVICE WAS UNRESPONSIVE AND NOTED THAT THE LED'S SCROLL CONTINUOUSLY. THE FLASH READ/WRITE PROTECTION BITS HAVE BECOME SET. 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 CONSUMER VIA A MANUFACTURER¿S REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY INCONTINENCE. IT WAS REPORTED THAT PATIENT HAD A RECHARGE SYSTEM WITH PROBLEM. THE NEW RECHARGING SYSTEM WAS DEFECTIVE. THERE ARE NO FACTORS THAT CONTRIBUTED TO THE PROBLEM. THE DEVICE HAS BEEN RESET. BUT WITHOUT SUCCESS. THE RECHARGER WILL BE RETURNED. FURTHERMORE, PATIENT WAS EXPERIENCING LESS THAN 50% THERAPY RELIEF. (B)(6) 2025 (B)(4) [WR], RPL (B)(4) [DOCK] (FOR, REP): NO NEW INFORMATION. (B)(6) 2025 (B)(4), (B)(4) (FOR, REP): NO NEW INFORMATION FOR THE EVENT DESCRIPTION. [(B)(4) WR SYSTEM PROBLEM].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386927 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION 97810 00763000596743

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female "SEE H11...."