BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3203347 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11240
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 7, 2013
    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 PRODUCTS: PRODUCT ID: 3093-28, LOT# V152141, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOMETIMES, WHEN THE PATIENT WENT THROUGH SECURITY GATES, HER DEVICE TURNED ON. THE PATIENT WAS CURRENTLY CATHETERIZING BECAUSE WHEN STIMULATION WAS ON, IT IRRITATED THE NERVES IN HER LEGS ¿AND STUFF¿. THIS REPORTEDLY STARTED AFTER THE PATIENT HAD BACK SURGERIES. IT WAS NOTED THAT THE PATIENT HAD HAD 5 BACK SURGERIES SINCE THE DEVICE WAS IMPLANTED. THE REPORTER INDICATED THAT THE DEVICE HELPED WITH THE PATIENT¿S BLADDER BUT CAUSED PAIN OR IRRITATED HER BACK AND LEGS. BECAUSE IT IRRITATED HER BACK AND LEGS, THE PATIENT HAD ALWAYS HAD TO MAKE ¿A LOT¿ OF ADJUSTMENTS. IT WAS NOTED THAT THE PATIENT TURNED STIMULATION ON, ¿EVERY ONCE IN A WHILE¿, BECAUSE IT HELPED WITH BLADDER PAIN. THE REPORTER STATED THAT THE PATIENT HAD NOT BEEN FEELING WELL, HER BACK AND BLADDER WERE BOTH "BOTHERING HER". IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303028 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1