BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3207139 · Received July 5, 2013

    Report

    Report Number
    3004209178-2013-11323
    Event Type
    Injury
    Date Received
    July 5, 2013
    Date of Event
    April 19, 2013
    Report Date
    June 11, 2013
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8590-1 LOT# N232981, IMPLANTED: 2009 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 8596SC LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8709SC LOT# SERIAL#(B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) DETERMINED THAT THE PUMP ¿WASN¿T FEEDING ANYTHING THROUGH¿. THE PATIENT STATED ¿IT WASN¿T FEEDING ANYTHING THROUGH BECAUSE, IT WASN¿T WORKING¿. THE HCP DETERMINED THAT THE CATHETER NEEDED TO BE REPLACED. THE CATHETER REPLACEMENT TOOK PLACE APPROXIMATELY 1.5 MONTHS PRIOR TO THE REPORT. THE DEVICE SYSTEM DELIVERED DILAUDID. 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
    308077 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention