BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2833717 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10299
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709. SERIAL # (B)(4), IMPLANTED: UNKNOWN, PRODUCT TYPE CATHETER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING MEDICATION SIDE EFFECTS WHICH REQUIRED HOSPITALIZATION. THE PATIENT WAS EXPERIENCING NAUSEA AND VOMITING AND THE INFUSION RATE WAS DECREASED ON (B)(6) 2012 AND MORPHINE WAS ADDED TO THE PUMP. IT WAS REPORTED AS AN ONGOING EVENT AS OF (B)(6) 2012. IT WAS LATER REPORTED THAT THE SIDE EFFECTS WERE POSSIBLY RELATED TO SPECIFICALLY FENTANYL. THE MEDICATIONS IN THE PUMP WERE FENTANYL, BUPIVACAINE AND CLONIDINE AND MORPHINE WHICH WAS ADDED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE PUMP RATE WAS DECREASED 22% ON (B)(6) 2012 AND DECREASED 29% ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT WAS GIVEN IV (INTRAVENOUS) SALINE. THE PUMP RATE WAS INCREASED 20% ON (B)(6) 2012. THE OUTCOME OF THE EVENT WAS REPORTED AS ¿RESOLVED WITHOUT SEQUELA ¿ RESOLVED (B)(6) 2012.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization| R