BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3802360 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08785
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    April 19, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 889-28, LOT# VA0F9MB, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NO STIMULATION SENSATION. IT WAS STATED THE PATIENT¿S STIMULATION WAS SET AT 0.9 VOLTS AND IT WAS CONFIRMED THAT THE STIMULATION WAS OFF. THE PATIENT TURNED THE STIMULATION BACK ON AND WAS FEELING STIMULATION AND CONFIRMED THEY WERE ABLE TO INCREASE STIMULATION. IT WAS STATED THE PATIENT HAD TO HAVE THEIR DEVICE REVISED FOUR DAYS PRIOR TO REPORT. IT WAS REPORTED THE PATIENT WAS PULLING UP THEIR JEANS AND THEIR FINGERS GOT UNDER THE IMPLANTABLE NEUROSTIMULATOR (INS) AND PULLED IT UP. REPORTEDLY, THE PATIENT STATED IT WAS KIND OF SIDEWAYS FOR 2-3 WEEKS. IT WAS NOTED THEY RE-IMPLANTED THE DEVICE MORE SECURE. THE PATIENT STATED IT WAS WORKING THE ENTIRE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281411 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