BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2223862 · Received August 18, 2011

    Report

    Report Number
    3004209178-2011-06557
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PARTIAL CATHETER BLOCKAGE WAS NOTED; DURING SPIRAL CT STUDY, DYE WAS OBSERVED EXITING THE PROXIMAL HOLES OF THE CATHETER. THE "CATHETER VOLUME WAS THEN PRIMED SINCE IT WAS THOUGHT CATHETER WAS EMPTY, RESULTING IN SUSPECTED BOLUS OF 114 MCG WHICH IS MORE THAN 4X THE DAILY DOSE". THE REPORTER SUSPECTED THAT THE NEEDLE WAS NOT IN THE CAP (CATHETER ACCESS PORT) AS 0.5 ML OF FLUID WAS WITHDRAWN; THE FLUID WAS DESCRIBED AS A "DARK YELLOW" FLUID. THE PUMP CONTAINED BACLOFEN. THE PT EXPERIENCED AN OVERDOSE WITH THE FOLLOWING SYMPTOMS: DIZZINESS, NAUSEA, RESPIRATORY DEPRESSION, WEAKNESS, LEG WEAKNESS, TROUBLE WALKING AND CLAMMINESS. THE PT WAS ADMITTED TO THE HOSPITAL TO BE MONITORED. TEN MLS OF CSF (CEREBROSPINAL FLUID) WERE WITHDRAWN "TO DILUTE THE DOSE WHICH PT HAD RECEIVED", THE CATHETER WAS ASPIRATED, THE PUMP WAS STOPPED AND "OVERDOSE PROTOCOL" WAS FOLLOWED. THE PT WAS PLACED BACK ON HIS DAILY DOSE OF 20MCG. THE PT LEFT HOSPITAL THE FOLLOWING DAY; THE PT'S DOSE WAS INCREASED TO 35MCG BEFORE HE LEFT THE HOSPITAL. THE OUTCOME OF THE EVENT WAS RESOLVED WITHOUT SEQUELA AS OF (B)(6) 2011.

    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 50 YR Hospitalization| R IMPLANTED:| CATHETER: MODEL 8731SC, LOT# N213759011| EXPLANTED: