BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2941648 · Received February 4, 2013

    Report

    Report Number
    3004209178-2013-01255
    Event Type
    Injury
    Date Received
    February 4, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709 SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID, 8578 SERIAL# (B)(46), IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE SYSTEM WAS REMOVED DUE TO INFECTION SOMETIME IN (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46863 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention