BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1960934 · Received January 11, 2011

    Report

    Report Number
    3004209178-2011-00270
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    August 19, 2010
    Report Date
    January 5, 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
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT WAS TRAVELING SO WENT TO A FACILITY DIFFERENT THAN HER NORMAL FACILITY TO HAVE THE PUMP REFILLED. THE PUMP WAS ACCESSED AND 4 CC OF FLUID WAS PULLED FROM THE PUMP. THE ASSISTANT THEN HAD TROUBLE LOCATING THE PUMP FILL PORT TO PERFORM THE REFILL. FOLLOWING THE REFILL, THE PT WAS HOSPITALIZED FOR AWHILE FOR AN OVERDOSE, BUT HAD SINCE RETURNED TO NORMAL THERAPY. THE DEVICE SYSTEM WAS USED TO DELIVER CLONIDINE AND BACLOFEN.

    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 59 YR Hospitalization IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT#: N131147007