BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3205580 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-11290
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 19, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8731 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: NE U_UNKNOWN_CATH LOT# SERIAL# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. A TIMELINE WAS NOT PROVIDED. AT THE TIME OF THE REPORT, THE DEVICE SYSTEM WAS USED TO DELIVER SALINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306488 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Other