BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5184418 · Received October 28, 2015

    Report

    Report Number
    3004209178-2015-21682
    Event Type
    Injury
    Date Received
    October 28, 2015
    Report Date
    October 5, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S) : PRODUCT ID: 309333, LOT# V220528, SERIAL# PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE PATIENT'S DEVICE DIDN'T SEEM TO HELP AND IT HAD BEEN OFF FOR 2 YEARS AND IN FOR 5 YEARS. THE PATIENT HAD DEVELOPED A PAIN RIGHT WHERE THE MONITOR WAS UNDER THE SKIN AND IT SEEMED TO CAUSE THE ENTIRE LEG TO ACHE. THE PATIENT'S FAMILY MEMBER DIDN'T WANT THE PATIENT TO HAVE SURGERY AGAIN TO REMOVE IT. THE PATIENT GOT IN TO SEE THEIR HEALTH CARE PROVIDER (HCP) AND THE HCP SAID THE DEVICE JUST SHIFTED. THE DEVICE JUST KIND OF SHIFTED OR MOVED DOWN OR SOMETHING, SO THE HCP WAS GOING TO REMOVE IT IN THE MIDDLE OF (B)(6) 2015. THE INDICATION FOR USE FOR THIS PATIENT WAS GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715819 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention