BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3944713 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-13246
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3889-28, LOT# VA0JXEU, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# VA0JXEU, IMPLANTED: (B)(6) 2014, 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 STIMULATION IN THE WRONG LOCATION. THE PATIENT STATED THE NIGHT BEFORE REPORTED EVENT DATE SHE BEGAN TO FEEL STIMULATION IN THE MIDDLE OF HER LEG AND TINGLING. THE PATIENT SAID IT FELT LIKE HER FOOT/LEG HAD FALLEN ASLEEP. THE PATIENT INITIALLY THOUGHT SHE HAD SLEPT WRONG, BUT THE PATIENT STATED THE SENSATION HAS CONTINUED THE MORNING OF REPORTED EVENT DATE. THE PATIENT STATED SHE WAS IMPLANTED ON MONDAY WITH 2 IMPLANTS FOR THE BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422280 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR