BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA LKK

    MDR report key: 802812 · Received January 3, 2007

    Report

    Report Number
    6000030-2007-00011
    Event Type
    Injury
    Date Received
    January 3, 2007
    Report Date
    August 4, 2006
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT STATES PHYSICIAN CONFIRMED A GRANULOMA - VIA MRI. PUMP WAS FILLED WITH SALINE. ADDITIONAL INFORMATION CONCERNING EVENT RESOLUTION AND PATIENT OUTCOME WILL BE PROVIDED WHEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK LKK LKK RICE CREEK MANUFACTURING 8709AA J12328R30

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention IMPLANTED:| NGV009035N| IMPLANTABLE INFUSION PUMP MODEL 863740 LOT #