BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4090211 · Received September 15, 2014

    Report

    Report Number
    3004209178-2014-17038
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    August 20, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# V675651, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PROBLEM WITH THE PATIENT PROGRAMMER. THE PATIENT WAS NOT ABLE TO MAKE ADJUSTMENT BOTH WITH OR WITHOUT ANTENNA ATTACHED. THE PATIENT HAS A RETURN IN SYMPTOMS AND POOR COMMUNICATION ON THE PROGRAMMER. THE PATIENT NOTICED TODAY THAT SHE WAS GOING TO THE BATHROOM MORE FREQUENTLY. THE PATIENT CANNOT TELL IF SHE WAS FEELING STIMULATION, SHE NORMALLY DOES NOT FEEL STIMULATION STRONGLY. THE PATIENT TRIED TO USE THE PROGRAMMER TODAY AND WAS SEEING THE POOR COMMUNICATION SCREEN. THE PATIENT TRIED TO USE THE PROGRAMMER WITH THE ANTENNA ON THE CALL AND SAW POOR COMMUNICATION. THE PATIENT TRIED TO USE THE PROGRAMMER WITHOUT THE ANTENNA ON THE CALL AND SHE SAW POOR COMMUNICATION. THE PATIENT ENSURED THAT THE ANTENNA CORD WAS PLUGGED IN ALL THE WAY. THE PATIENT TRIED REPOSITIONING THE ANTENNA. THE PATIENT TRIED CHANGING THE PROGRAMMER BATTERIES, THESE ACTIONS DID NOT RESOLVE THE ISSUE. IT WAS NOTED THAT THE PATIENT DOES NOT HAVE A PHYSICIAN AT THIS TIME. THE PROGRAMMER WILL NOT WORK WITH THE ANTENNA. IT WAS REPORTED A DAY LATER THAT THE PATIENT STILL NOT ABLE TO CONNECT USING PATIENT PROGRAMMER THAT WAS SENT BY REPAIR. THE PATIENT STATES THAT SHE WAS USING (B)(6) 'DURALOCK' BATTERIES. THE PATIENT REPORTS A LOSS OF THERAPEUTIC EFFECT. IT WAS REPORTED THAT THE PATIENT WAS CURRENTLY NOT FEELING STIMULATION. UPON DEVICE RETURN, ANALYSIS FOUND TELEMETRY PROBLEM. THE ANTENNA JACK WAS RESOLDERED AS A PREVENTIVE MEASURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568800 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR