BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2643709 · Received July 6, 2012

    Report

    Report Number
    3004209178-2012-05296
    Event Type
    Malfunction
    Date Received
    July 6, 2012
    Report Date
    June 8, 2012
    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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD, MODEL 3889-28, LOT# V933650, IMPLANTED: (B)(6) 2012, EXPLANTED: NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE PATIENT WAS NOT FEELING STIMULATION OR GETTING RELIEF. THE DEVICE WAS POWERED OFF. THE CALLER WAS TAUGHT HOW TO USE THE PATIENT PROGRAMMER, TURN THE INS ON, AND ADJUST THE SETTINGS ON PROGRAM 2 TO 7.0V. IT WAS REPORTED THAT SOMETIMES THE PATIENT HAD URGE AND HER HUSBAND COULD GET A BED PAN UNDER HER, BUT OTHER TIMES IT HAPPENED SO FAST THAT HE COULD NOT. IT WAS NOTED THAT THE PATIENT HAD BEEN ON PROGRAM 2 SINCE IMPLANT. THE PATIENT PLANNED TO MONITOR HER SYMPTOMS ON THE NEW SETTINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1