BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4240893 · Received November 10, 2014

    Report

    Report Number
    3004209178-2014-21235
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 16, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3 889-28, LOT# V706432, IMPLANTED: 2011-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED ON THE DAY OF THIS CALL THAT THEY WERE NOT BEING ABLE TO ADJUST STIMULATION AND THE DISPLAY ON THE PATIENT PROGRAMMER SHOWING "CALL YOUR DOCTOR" ICON AND A POWER ON RESET (POR) CONDITION. THE PATIENT WAS REDIRECTED TO HEALTH CARE PROVIDER TO CLEAR THE POR. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. A FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722349 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR