BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2160916 · Received June 16, 2011

    Report

    Report Number
    3004209178-2011-04476
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 18, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE ACTUAL RESIDUAL VOLUME (36 ML) WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (2.3 ML), "BUT ONLY REFILLED WITH 20 ML". THE FLUID ASPIRATED HAD A LIGHT-YELLOW COLOR. THE HCP WAS CONCERNED THAT CSF WAS FLOWING BACK INTO THE PUMP. THE PUMP LOGS WERE REVIEWED AND NOTHING ABNORMAL FOUND. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE (10 MG/ML). ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 81 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J11947R01