BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 11269110 · Received February 2, 2021

    Report

    Report Number
    3004209178-2021-01837
    Event Type
    Injury
    Date Received
    February 2, 2021
    Report Date
    February 2, 2021
    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
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR THERAPY. THE PATIENT (PT) REPORTED THEIR FIRST INS "MALFUNCTIONED" AND "WAS NO GOOD". PT STATED THIS OCCURRED "SEVERAL YEARS AGO" AND REPORTED "THEY KNEW SOMETHING HAPPENED". CLARIFIED THIS OCCURRED "WITHIN A YEAR" OF IMPLANT. PT STATED HCP HAD REPS COME IN DUE TO THIS. AGENT DID NOT ASK ABOUT THE CIRCUMSTANCES THAT LED TO THE REPORTED ISSUE. DOCUMENTED HISTORICAL INFORMATION PT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162889 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention