BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2810376 · Received October 31, 2012

    Report

    Report Number
    3004209178-2012-09772
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    October 5, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN ASPIRATING THE PUMP THE PHYSICIAN "GOT BACK" 5 CCS LESS THAN HE THOUGHT HE SHOULD HAVE. A DYE AND ROLLER STUDY WERE DONE AND BOTH "LOOKED NORMAL" ON (B)(6) 2012. IT WAS ALSO NOTED THAT WHEN THE PUMP WAS LOW, THE PATIENT HAD AN ABNORMAL SMELL AND TASTE. THE PATIENT HAD NO INJURY. THE DRUGS IN THE PUMP WERE HYDROMORPHONE, BUPIVACAINE, AND PRIALT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1