BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 9946519 · Received April 9, 2020

    Report

    Report Number
    3004209178-2020-07006
    Event Type
    Malfunction
    Date Received
    April 9, 2020
    Date of Event
    January 1, 2020
    Report Date
    April 9, 2020
    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
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE IS APPROXIMATE WITH MONTH/YEAR VALIDITY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION. A LOSS OF THERAPEUTIC EFFECT WAS REPORTED BY THE PATIENT. THE PATIENT REPORTED THAT IN THE FIRST WEEK OF JANUARY THEY HIT THEIR INS SITE ON THE CORNER OF A TABLE SO THEY WENT TO THEIR HEALTH CARE PHYSICIAN (HCP) OFFICE, THEY CHECKED THE IMPLANT AND SINCE EVERYTHING HAD BEEN WORKING AS INTENDED THE HCP INCREASED THEIR STIMULATION. TWO DAYS LATER, SINCE THEIR INS WAS ¿FINE,¿ THE PATIENT WENT TO THE CHIROPRACTORS OFFICE, THE CHIROPRACTOR PUSHED ON THEIR INS SITE AND THE PATIENT ¿GOT A ZING.¿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¿T RESOLVE. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408717 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR