BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3213234 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11466
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Report Date
    June 12, 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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3093-28, LOT# V573632, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3093-28, LOT# V573632, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR THE PAST FEW DAYS, THE PATIENT¿S BLADDER HAD STARTED GETTING ¿REALLY SORE¿.THEREFORE, THE PATIENT TRIED TO TURN STIMULATION UP OR CHECK IF IT WAS OFF AND WAS UNABLE TO MAKE A CONNECTION USING THE PATIENT PROGRAMMER. THE REPORTER INDICATED THAT THE PATIENT HAD IT SET REALLY LOW SO SHE DIDN¿T ALWAYS FEEL STIMULATION. IT WAS NOTED THAT THE PATIENT ¿HAD A LEAD THAT WASN¿T REGISTERING¿. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312222 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1