BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3053014 · Received April 11, 2013

    Report

    Report Number
    3004209178-2013-06015
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 25, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 093-33, LOT# V699318, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR TURNED OFF THE DEVICE BECAUSE IT WAS NOT WORKING IN (B)(6) 2012. IT WORKED AT FIRST AND THEN IT STOPPED WORKING. THE DEVICE WAS HURTING AND THE PATIENT COULD NOT SIT DOWN OR SLEEP ON HER LEFT SIDE. IT HURT IN HER LOWER BACK AROUND WHERE THE WIRE WAS AND HER BACK "KILLS HER". IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155670 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1