BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2543360 · Received April 20, 2012

    Report

    Report Number
    3004209178-2012-02548
    Event Type
    Malfunction
    Date Received
    April 20, 2012
    Report Date
    March 24, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3889-28, LOT# V251860, IMPLANTED: 2009 (B)(6), EXPLANTED: PROGRAMMER MODEL 3037, SERIAL# (B)(4).

    Description of Event or Problem · 1

    THERE WERE SOME DISCONNECTIONS IN THE PATIENT'S DEVICE SYSTEM. SHE HAD HER DEVICE PROGRAMMED AROUND THE DISCONNECTIONS ON MARCH 22ND. THERE WERE SOME ISSUES WITH COMMUNICATION WITH THE PATIENT PROGRAMMER. REPLACING THE BATTERIES SEEMED TO HELP BUT THE COMMUNICATION WAS STILL INTERMITTENT WHEN USING THE ANTENNA. WHEN THE ANTENNA WAS UNPLUGGED IT WORKED. IT WAS DETERMINED THAT THE STIMULATION WAS ON AT 1.4V. SHE STARTED TO EXPERIENCE A THROBBING SENSATION IN HER HIPS TODAY AND IT WENT AWAY ONLY WHEN THE STIMULATION WAS TURNED OFF NOT DECREASED. SHE WAS GOING TO CONTACT HER DOCTOR ON MONDAY TO HAVE THE DEVICE SYSTEM CHECKED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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