BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2407329 · Received January 10, 2012

    Report

    Report Number
    3007566237-2012-00078
    Event Type
    Malfunction
    Date Received
    January 10, 2012
    Report Date
    December 20, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3889-28, LOT# V842736, IMPLANTED: 2011-(B)(6), EXPLANTED: NA. PROGRAMMER MODEL 3037, SERIAL# (B)(4). (B)(4)

    Description of Event or Problem · 1

    FOLLOWING A RECENTLY IMPLANTED NEUROSTIMULATOR (INS), IT WAS REPORTED THAT THE PATIENT COULD NOT ADJUST THE STIMULATION. A POWER ON RESET MESSAGE WAS DISPLAYED ON THE PATIENT PROGRAMMER WHICH WAS RESOLVED. SUBSEQUENTLY, THE PATIENT COULD AGAIN NOT ADJUST THE STIMULATION DUE TO A CALL YOUR DOCTOR MESSAGE ON THE PATIENT PROGRAMMER AND COULD NO LONGER FEEL THE STIMULATION. IT WAS NOT KNOWN IF THE PATIENT COULD TYPICALLY FEEL THE STIMULATION WITH THE INS ON. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    THE DOCTOR WIPED OUT THE PROGRAM AND RESET EVERYTHING SO WHEN THE PATIENT TRIED TO DO ANYTHING HE GOT THE ERROR MESSAGE. THE DEVICE WAS RE-SYNCHED WITH EVERYTHING AND ISSUE RESOLVED. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 PROGAMMER MODEL 3037, SERIAL # UNKNOWN