BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2781461 · Received October 10, 2012

    Report

    Report Number
    3004209178-2012-09090
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Report Date
    September 21, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA01LNQ, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DAYS AFTER IMPLANT OF AN IMPLANTABLE NEUROSTIMULATOR (INS) THE PATIENT FELT SICK FROM ANESTHESIA, AND THAT THE PATIENT WAS BEING SHOCKED AND JOLTED BY THE INS. PATIENT HAD SEEN AN IMPROVEMENT, ON AVERAGE FOUR TIMES IN DURATION, BETWEEN URINARY FREQUENCY SINCE IMPLANT. IT WAS REPORTED THAT "IT IS MUCH BETTER THAN HOW THINGS WERE BEFORE SHE GOT THE THERAPY." IT WAS ALSO REPORTED THAT THE PERMANENT SYSTEM "DOESN'T QUITE SHOCK EVERY NOW AND AGAIN AT ALL."

    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