BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3968385 · Received July 30, 2014

    Report

    Report Number
    3004209178-2014-13725
    Event Type
    Malfunction
    Date Received
    July 30, 2014
    Report Date
    July 15, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-33, LOT # V062019, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3093-33, LOT # V062019, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STATES THAT AFTER HER REVISION FOR DEVICE MIGRATION IT WAS WORKING 'FINE' AND THEN IT STARTED SENDING IMPULSES TO WRONG PLACES, TOES TO KNEES, MUSCLES IN THIGH, IN HER CALF AND TWITCHING. THE ISSUE BEGAN SUDDENLY IN 2009 PER CALLER. IT WAS NOTED THAT THE PATIENT AT NO POINT REACHED OUT TO HER HEALTHCARE PROVIDER. IT WAS NOTED LAST CONTACT WAS IN 2008. THE PATIENT STATES SHE LOWERED HER 'INTENSITY' (VOLTAGE) AT THIS TIME. EVENTUALLY, THE PATIENT REPORTS SHE TURNED IMPLANT OFF ALL TOGETHER AND IT HAS BEEN OFF FOR 4 YEARS. THE PATIENT NOTES SHE HAS HAD OTHER HEALTH ISSUES AND SHE HAS BEEN BUSY WITH THOSE RATHER THAN HER STIMULATOR. LATELY SHE HAS DEVELOPED MORE SERIOUS HEALTH ISSUES (LUPUS, KIDNEY ISSUES) AND THE PATIENT CANNOT DO AN MRI. THE PATIENT NOTES THAT THE LAST 2 YEARS THAT THE DEVICE HAS BEEN HURTING HER. THE PATIENT SAYS THERE WERE ALL KIND OF THINGS HAPPENING WHERE THE LEADS WERE. THEY BURN, HURT AND IT FEELS LIKE THEY WERE STUCK SOMEWHERE. THE PATIENT STATES SHE WAS LOOKING FOR A DOCTOR TO REMOVE HER IMPLANT AND SHE SPOKE WITH AN MANUFACTURER REPRESENTATIVE TWO MONTHS AGO ABOUT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445396 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR