BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2831623 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10243
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    October 16, 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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V573632, IMPLANTED: (B)(6) 2010, 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 THE PATIENT HAD HER STIMULATION TURNED OFF THE TUESDAY PRIOR TO THE REPORT BECAUSE THE STIMULATION "SHOT THROUGH" HER LEG, SHE WAS IN "EXCRUCIATING" PAIN, AND IT "FLIPPED HER LEG UP A COUPLE TIMES". THE PATIENT INDICATED SHE HAD SYMPTOMS FOR A WEEK; HER LEG GOT NUMB AND SHE DID NOT FEEL IT AND HER FOOT GOT WARM. IT WAS ALSO REPORTED THAT THE PATIENT HAD KIDNEY PAIN THE NIGHT PRIOR TO THE REPORT. THE PATIENT GOT "LIGHTHEADED" AS THE DAY WENT ON AND DID NOT FEEL "GOOD". THE SYMPTOM HAD BEEN GOING ON FOR A WEEK WHILE THE STIMULATION WAS TURNED OFF. THE PATIENT DID NOT KNOW IF IT WAS HER BODY REACTING TO THE STIMULATION BEING "TURNED OFF OR WHAT". THE DAY PRIOR TO THE REPORT THE DEVICE WAS TURNED BACK ON, BUT THE PATIENT COULD ONLY TOLERATE A SETTING OF 0.1, WHEN TYPICALLY SHE WAS ON 4.0 BEFORE. WHEN TURNED ON IT "SHOT THROUGH" THE BACK OF THE PATIENT'S THIGH AND UP TO HER BUTTOCKS. THE PATIENT ALSO HAD A "FUNNY FEELING" IN HER FOOT, LIKE A "TICKLE", AND WHEN THE FOOT HIT THE GROUND IT FELT LIKE A "ZAP". IT WAS ALSO REPORTED THAT THE PATIENT BELIEVED SHE WAS TOLD ONE OR TWO OF HER LEADS WERE NOT WORKING. THE PATIENT ALSO STATED THAT A LEAD MAY HAVE MOVED BECAUSE THERE WAS AN ISSUE WITH "PRESSURE PUT ON HER BACK" AND HAD PROBLEMS SINCE THEN. ADDITIONAL INFORMATION WAS 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