BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2040765 · Received March 22, 2011

    Report

    Report Number
    3004209178-2011-02200
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 3, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN 2009, IT WAS REPORTED THAT THE PT'S LEGS WERE WEAK AND HIS FEET HURT. THE PT'S MEDICATION DOSAGE WAS SLOWLY BEING INCREASED. THE PT HAD MORE PAIN THAN NORMAL WITH THIS PUMP. ABOUT (B)(6) LATER, THE PT BEGAN EXPERIENCING INCREASED BASELINE SPASTICITY, LEG WEAKNESS, AND GAIT CHANGES. HE FELT LIKE HE WAS LOSING HIS FEET. IT FELT LIKE HE WAS GETTING SHOCKED. THE PT USED CRUTCHES TO WALK. HE HAD SEVERAL FALLS. THE PT WAS IN CONTACT WITH HIS HCP. NO DIAGNOSTIC STUDIES HAD BEEN DONE BY THE TIME OF THE REPORT. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N197321007| EXPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNK