BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3374967 · Received September 30, 2013

    Report

    Report Number
    6000030-2013-00223
    Event Type
    Injury
    Date Received
    September 30, 2013
    Report Date
    September 27, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE INFORMATION IN THIS REPORT HAS ALREADY BEEN SUBMITTED UNDER MANUFACTURER REPORT # 6000030-2007-02037.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492560 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention