BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3892260 · Received June 24, 2014

    Report

    Report Number
    3004209178-2014-11985
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 3093-28, LOT# V863548, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAS A UTI (URINARY TRACT INFECTION) AND WAS TAKING SHOTS FOR IT AND HUSBAND WANTED TO KNOW HOW CLOSE SHE CAN GET TO THE INS (STIMULATOR). HE WAS CURRENTLY DOING SHOTS ON THE OPPOSITE SIDE AND THE PATENT WAS GETTING SORE. UTI STARTED LAST WEEK TO A MONTH AGO CALLER WAS UNSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369285 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention