BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2171005 · Received June 30, 2011

    Report

    Report Number
    3004209178-2011-04977
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED INCREASED SPASTICITY AND UNDERWENT PUMP REPLACEMENT SURGERY ON (B)(6) 2011 DUE TO DEVICE END OF LIFE. DURING THE SURGERY, A PREIMPLANT PRIME OF A NEW PUMP WAS PROGRAMMED ON THE BACK TABLE. A PRIME VOLUME OF 0.3 MLS OVER 19 MINS DURATION WAS PROGRAMMED. THE PUMP WAS STILL DRIPPING AND 3-4 DROPS WERE NOTED A FEW MINS AFTER THE 19 MINS ELAPSED. THE PRIME WAS PROGRAMMED AT TIME 1408 PER THE SESSION REPORT; THE SECOND UPDATE WAS PERFORMED AT 1430 TO PROGRAM THE PUMP TO STOPPED MODE AND CANCEL BOLUS WAS SELECTED. PUMP WAS NOT RE-INTERROGATED AFTER THE FIRST BOLUS WAS COMPLETE. THE PLAN WAS TO PROGRAM THE PUMP TO SIMPLE CONTINUOUS MODE AS THE PT HAD BEEN WITHOUT DRUG "FOR A LITTLE WHILE." THE PUMP WAS IMPLANTED. BACLOFEN 280.6MCG, 2,000MCG/ML WAS USED IN THE PUMP. THERE WERE NO FURTHER ISSUES AFTER THE IMPLANTATION. ADDITIONAL INFO WILL BE REPORTED IF IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR IMPLANTABLE INFUSION PUMP: MODEL 863740| IMPLANTED:| EXPLANTED:| LOT# NGV010268N| CATHETER: MODEL 8703W, LOT# L57745| EXPLANTED:| IMPLANTED: