BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3640142 · Received February 21, 2014

    Report

    Report Number
    3004209178-2014-03430
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Report Date
    January 31, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# V161901, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT WAS REPROGRAMMED ON (B)(6) 2011. TURNED UNIT OFF THEN ON AGAIN. THE PATIENT HAS NOT FOLLOWED UP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S STIMULATION WAS TURNING ON. THE PATIENT WAS CURIOUS IF THIS COULD CAUSE PAIN DOWN THEIR LEG SUDDENLY. IT WAS NOTED THAT THE EVENT OR SYMPTOMS HAD BEEN OCCURRING FOR ABOUT 4 DAYS PRIOR TO THE REPORT. THERE WERE NO FALLS OR TRAUMA REPORTED. IT WAS NOTED THAT THE PATIENT WAS GOING TO TURN DOWN THEIR IMPLANTABLE NEUROSTIMULATOR TO SEE IF THAT HELPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109063 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR