BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3773056 · Received April 25, 2014

    Report

    Report Number
    3004209178-2014-08103
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    August 5, 2009
    Report Date
    April 3, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 093-33, LOT# V250971, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE WAS NOT WORKING AND THEY WOULD LIKE TO SEND THE MACHINE BACK. THE PATIENT WAS GOING TO HAVE THEIR DEVICE REMOVED THIS SUMMER. IT WAS NOTED THAT THE PATIENT WAS IMPLANTED TWICE AND THEIR HEALTH CARE PROVIDER (HCP) WANTED TO TRY AGAIN BUT THE PATIENT WAS NOW CATHETERIZING EVERY DAY AND WAS NOT GOING TO FOOL WITH IT. IT WAS STATED THAT IT WAS GOING TO BE ANOTHER SURGERY TO PUT IT IN AND THEN IF IT DIDN¿T WORK THE PATIENT WOULD HAVE TO HAVE ANOTHER SURGERY SO THEY WERE GOING TO HAVE IT TAKEN OUT THIS SUMMER. THE PATIENT SPOKE WITH THEIR PRIMARY CARE PHYSICIAN AND THEY TOLD THE PATIENT THAT IT WAS NOT REALLY WORTH TRYING AGAIN BECAUSE IF IT HADN¿T WORKED TWICE, WHO SAID IT WAS GOING TO WORK THE THIRD TIME. IT WAS REPORTED THAT NOW THE PROBE STILL WAS NOT CONNECTED RIGHT AND THE PATIENT WAS JUST NOT GOING TO FOOL WITH IT. THE PATIENT WOULD CALL BACK AFTER THEY HAD THEIR DEVICE REMOVED TO RETURN THEIR PROGRAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251474 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention