BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2861664 · Received December 7, 2012

    Report

    Report Number
    3004209178-2012-11272
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    November 7, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC LOT# N314626005, IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A SIGNIFICANT DECREASE OF PAIN RELIEF. A SIDE PORT ASPIRATION WAS ATTEMPTED AND FAILED. A CATHETER REVISION WAS SCHEDULED FOR (B)(6). THE PUMP WAS USED TO DELIVER PRIALT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED NO CATHETER WAS EXPLANTED, BUT A NEW CATHETER WAS PUT IN. THE PATIENT WAS DOING WELL AND FEELING RELIEF WITH MEDICATION. IT WAS LATER REPORTED THE OLD CATHETER WAS CAPPED AND LEFT IN. THE NEW CATHETER WAS IMPLANTED ON (B)(6) 2012 AND THE PATENCY OF THE NEW CATHETER WAS VERIFIED WITH SIDE PORT ASPIRATION PRIOR TO CLOSE. PRIALT WAS DISCONTINUED IN THE PUMP WAS USED TO DELIVER BUPIVACAINE AT 4 MILLIGRAMS PER DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention