BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1190361 · Received October 6, 2008

    Report

    Report Number
    6000030-2008-06362
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    January 1, 2007
    Report Date
    September 8, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED MENINGITIS 3 WEEKS POST IMPLANTATION OF HIS FIRST PUMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention PROGRAMMER MODEL PROGRAMMER LOT # UNKNOWN| EXPLANTED| CATHETER MODEL 8709 LOT #N088346002 IMPLANTED