BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1981415 · Received February 1, 2011

    Report

    Report Number
    3004209178-2011-00770
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 25, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS ALARMING. TELEMETRY CONFIRMED A CRITICAL ALARM WAS OCCURRING. THE ALARM WAS DUE TO ZERO ML RESERVOIR VOLUME BEING REACHED. THEY WERE ABLE TO ASPIRATE THE RESERVOIR, BUT WERE UNABLE TO FILL IT. AFTER REVIEWING THE LOCKED RESERVOIR VALVE PROCEDURE, THEY WERE ABLE TO SUCCESSFULLY FILL THE RESERVOIR. THE PT WAS ASYMPTOMATIC; SHE HAD ORAL PAIN MEDS TO SUPPLEMENT. IT WAS ALSO NOTED THAT THE REFILL CYCLE SHOULD HAVE BEEN 66.6 DAYS BUT THE RESERVOIR WAS DRY AT 42 DAYS. THERE WERE NO DOSE OR CONCENTRATION CHANGES DURING THE REFILL CYCLE. THE DEVICE SYS WAS USED TO DELIVER DILAUDID AND BUPIVACAINE. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U 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 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR CATHETER: MODEL 8711, LOT# N126735001| ACCESSORY: MODEL 8590-1, LOT# N121609| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED: