BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3245579 · Received July 24, 2013

    Report

    Report Number
    3004209178-2013-12244
    Event Type
    Injury
    Date Received
    July 24, 2013
    Report Date
    June 28, 2013
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3889-28, LOT# V142990, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S FIRST IMPLANT ¿DISLODGED¿ AND WAS REPLACED IN (B)(6) 2011. PATIENT NOTED THE IMPLANT DIDN¿T WORK ANY BETTER THAN THEIR CURRENT IMPLANT. THE PATIENT NEVER HAD THERAPEUTIC EFFECT BUT DID NOTE IT WOULD OCCASIONALLY GIVE HER A LITTLE BIT OF RELIEF WHERE THEY COULD SLEEP FOR THREE HOURS BUT THEY ALSO THOUGHT THAT COULD HAVE BEEN BECAUSE THEY WERE SUPER TIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346760 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