BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3923653 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12753
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    December 7, 2012
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3889-33, LOT# VA04M3H, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3889-33, LOT# VA04M3H, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HAD URINARY TRACT INFECTIONS (UTIS) ALL THE TIME AND IT PRETTY MUCH WAS A CHRONIC THING. THE PATIENT HAD HAD THIS ISSUE SINCE BEFORE THE TIME OF IMPLANT AND THEY WENT TO SEE THEIR HEALTH CARE PROVIDER (HCP) AND HAD THE IMPLANTABLE NEUROSTIMULATOR (INS) CHECKED BECAUSE IT HADN¿T BEEN CHECKED IN A WHILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400095 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention