BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2140966 · Received June 21, 2011

    Report

    Report Number
    3004209178-2011-04648
    Event Type
    Injury
    Date Received
    June 21, 2011
    Report Date
    May 25, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS ALARMING AND HAD A "PUMP IS BLOCKED" ERROR MESSAGE. ON (B)(6) 2011, THE PUMP WAS EMPTIED AND REFILLED WITH 20ML. ON (B)(6) 2011, THE PUMP WAS STILL BLOCKED. PREVIOUS REFILLS: (B)(6) 2011 40ML MORPHINE 1MG/ML, 0.5MG/DAY; (B)(6) 2011 40ML MORPHINE 1MG.ML, 0.4MG/DAY. NO DEPRIVATION SYMPTOMS WERE REPORTED. BECAUSE OF THE CATHETER PLACEMENT, NEITHER CONTRAST TEST NOR PUMP ROTOR TEST WERE PERFORMED. A BOLUS WAS NOT ADMINISTERED. THE PUMP AND CATHETER WERE REVIEWED INTRAOPERATIVELY. THE CATHETER WAS PERMEABLE, HAD NO LEAKS AND WAS NOT REPLACED. THE PUMP WAS EXPLANTED AND REPLACED. THE PATIENT WAS REPORTED TO BE DOING "OK".

    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 51 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731SC, LOT# UNKNOWN