BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1623592 · Received March 2, 2010

    Report

    Report Number
    MW5014998
    Event Type
    Injury
    Date Received
    March 2, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 2, 2010
    Product Code
    EZW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD AN INTERSTIM IMPLANT FOR A YEAR IT NEVER READY HELPED VERY MUCH WITH MY BLADDER CONTROL PROBLEMS. AT THE ONE YEAR MARK THE IMPLANT SITE BECAME VERY INFECTED AND THE DEVICE WAS PROTRUDING OUT OF MY BODY. THE DOCTOR SAID MY BODY WAS REJECTING IT. SO IT WAS SURGICALLY REMOVED. THE DOCTOR SAID THIS IS VERY UNCOMMON. MOST OF THE TIME IF YOUR BODY IS GOING TO REJECT IT, IT WOULD BE RIGHT AWAY. I GUESS PEOPLE NEED TO KNOW THAT THIS CAN HAPPEN. IT WAS TOLD TO REPORT THIS INFORMATION TO YOU FROM THE (B) (4) PRESIDENT. DATES OF USE: CONTINUALLY (B) (6) 2009 -- (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: BLADDER CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INTERSTIM EZW

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| S