BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3620510 · Received February 10, 2014

    Report

    Report Number
    3004209178-2014-02716
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Report Date
    January 13, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# V192542, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS SENT A REPLACEMENT PROGRAMMER AND IT ¿WASN¿T WORKING¿ FOR THEM. THEY COULD NOT USE IT. IT WAS NOT CONNECTING WITH OR WITHOUT THE ANTENNA AND THE PATIENT WAS ¿CONVINCED¿ IT WAS THEIR ¿INTERNAL UNIT.¿ IT WAS NOTED THE PATIENT HAD BEEN TRYING TO GET ¿IT (STIMULATION) WORKING¿ FOR SEVERAL WEEKS. IT WAS ADDED THE PATIENT WAS GETTING ¿NOTHING¿ ON THE SCREEN. WITH TROUBLESHOOTING, THE PATIENT WAS ABLE TO GET THE POOR COMMUNICATION/REPOSITION ANTENNA SCREEN. THE PATIENT WANTED A REPRESENTATIVE TO CHECK THEIR PROGRAMMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87119 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1