BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2061939 · Received April 5, 2011

    Report

    Report Number
    3004209178-2011-02603
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS INTERROGATED AND MULTIPLE "RESET OCCURRED - LOW BATTERY" MESSAGES WERE RECORDED IN THE PUMP LOGS. THE ERI (ELECTIVE REPLACEMENT INDICATOR) WAS 34 MONTHS. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN 500 MCG/M. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT 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 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N105403007