BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3120635 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07918
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 29, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28 LOT# V705291, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3037 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOST OR STOLEN PATIENT DEVICE. THE REPLACEMENT DEVICE WAS ORDERED FOR THE PATIENT: 3037 PATIENT PROGRAMMER AND ANTENNA. THE PATIENT JUST GOT OUT OF THE HOSPITAL "TWO WEEKS AGO YESTERDAY" ((B)(6) 2013) DUE TO HEART PROBLEMS AND STROKE. IT WAS NOTED THIS WAS NOT RELATED TO HER INTERSTIM THERAPY. THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT WITH LOSS OF BLADDER CONTROL. IT WAS NOTED THAT "EVERY TIME I GO INTO THE HOSPITAL" THE PATIENT WOULD NOTICE A LOSS OF THERAPEUTIC EFFECT AND HER THERAPY "GOES TO SLEEP" FOR ABOUT 3 OR 4 WEEKS. IT WAS NOTED THAT "IT WILL WAKE ITSELF UP BUT IT WAKES UP REAL SLOW". DURING THE PATIENT'S RECENT STAY IN THE HOSPITAL SHE HAD TO USE "PADS" AND "PAMPERS" FOR BLADDER INCONTINENCE. THE PATIENT LOCATION WAS HOME. THE PATIENT PLANNED TO TURN HER STIM UP ONCE SHE RECEIVED HER NEW PROGRAMMER, IN ORDER TO HELP HER INCONTINENCE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIDN'T KNOW IF BEING SICK TURNED THEIR DEVICE OFF TO WHERE IT WASN'T STIMULATING THEM. THE DEVICE "CLICKED" ITSELF BACK IN AFTER THE TIMES WHEN IT WAS NOT WORKING PROPERLY. IT WAS NOTED THAT THE PROBLEMS USUALLY BEGAN A DAY OR 2 AFTER THE PATIENT WENT IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222174 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1