BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2704499 · Received August 17, 2012

    Report

    Report Number
    3004209178-2012-07023
    Event Type
    Malfunction
    Date Received
    August 17, 2012
    Report Date
    July 19, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# V952169, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION ON HER LEFT SIDE WHICH HAD BEEN OCCURRING SINCE IMPLANT. THE IMPLANTABLE NEUROSTIMULATOR WAS IMPLANTED ON THE LEFT SIDE AND WAS NOT TURNED ON UNTIL THE NEXT DAY. THE SHOCKING SENSATION WAS PAINFUL AND OCCURRED WHEN THE PATIENT WOULD BEND, SIT, USE THE TOILET, OR DRIVE. THE SHOCKING OCCURRED ABOUT 10-20 TIMES PER DAY ON THE PATIENT'S LEFT "U-WHO" WHILE BENDING. THERE WAS ALSO TINGLING IN THE LEFT BUTT CHECK WHICH WAS ANNOYING BUT TOLERABLE. THE INS WAS TURNED ON THE DAY FOLLOWING IMPLANT, WHICH HELPED RELIEVE THE SHOCKING IN THE LEFT LEG, BUT NOT THE SHOCKING ON THE LEFT SIDE OF HER "U-WHO" WHEN BENDING OVER OR SITTING DOWN. THE INS HAD BEEN TURNED OFF SINCE (B)(6) 2012. THE PATIENT WENT INTO STORES ON (B)(6)2012 WITH HER INS POWERED OFF AND THE ALARM WENT OFF. UPON EXITING A DIFFERENT DOOR, SHE STAYED IN THE MIDDLE OF THE SECURITY GATE AND RECEIVED A SHOCKING SENSATION FOR 1.5 MINUTES. IT WAS ALSO NOTED THAT THE PATIENT'S BELLY, LEG, AND FEET WERE SWOLLEN FOLLOWING IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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