BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2193078 · Received July 21, 2011

    Report

    Report Number
    3004209178-2011-05655
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED RETURN OF SYMPTOMS AFTER A CEPHALIC MRI WAS PERFORMED ON (B)(6) 2011. PER THE REPORTER, "FROM THAT MOMENT ON, HE STARTED FEELING BAD (RETURN OF SYMPTOMS)." NO INTERROGATION OF THE PUMP WAS PERFORMED AFTER THE MRI. PUMP LOGS NOTED THE FOLLOWING MESSAGES: "MOTOR STALL OCCURRED" ON (B)(6) 2011; "STOPPED PUMP MAY EXCEED TUBE SET" ON (B)(6) 2011. THE PHYSICIAN REPROGRAMMED THE PUMP ON (B)(6) 2011, INCREASING THE DOSAGE FROM 70 TO 90 MCG/DAY OF BACLOFEN 500 MCG/ML. IT WAS THEN NOTED "MOTOR STALL RECOVERY OCCURRED." PER THE RPTR, NO OTHER ACTION WAS PERFORMED: "THE PT IS UNDER CONTROL." THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1