BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2921095 · Received January 17, 2013

    Report

    Report Number
    3004209178-2013-00737
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 28, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT# L61551, IMPLANTED: 1999-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS LATER REPORTED THAT THE PATIENT WAS DOING WELL OVERALL ON FENTANYL, IT WAS NOT REPORTED WHAT ROUT THE PATIENT WAS RECEIVING MEDICATION. IT WAS NOTED THAT THERE WAS "NO REAL COMPLAINT OF WITHDRAWAL." IT WAS ALSO NOTED THAT THE PATIENT "SAW ID, NO MORE ATB AS CULTURES WERE NEGATIVE." IT IS UNCLEAR WHAT WAS MEANT. THE PATIENT HAS SEEN WOUND CARE AND THE PLAN WAS TO PROCEED WITH FURTHER DEBRIDEMENT OF THE WOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED DUE TO INFECTION. ABOUT TWO WEEKS LATER, IT WAS REPORTED THE INFECTION WAS AT THE PUMP POCKET SITE. IT WAS STATED THAT CULTURES HAD BEEN TAKEN. THE DRUGS USED IN THIS SYSTEM WERE MORPHINE AND BUPIVACAINE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26050 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention