BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3973876 · Received August 1, 2014

    Report

    Report Number
    6000030-2014-00103
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 8, 2014
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 863740, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PUMP. PRODUCT ID: 8709, LOT# J11037R69, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, IN 2007, THE PATIENT¿S PUMP WAS REPLACED BECAUSE OF A RECALL. IT WAS NOTED THAT MORPHINE HAD BEEN IN THE PUMP SINCE ¿DAY ONE¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450366 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention