BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED

    MDR report key: 1686034 · Received May 11, 2010

    Report

    Report Number
    6000030-2010-03876
    Event Type
    Death
    Date Received
    May 11, 2010
    Report Date
    April 16, 2010
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004/S31
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    THE PATIENT DIED DUE TO INFECTION. IT WAS NOT CLEAR IF THE DEVICE WAS INVOLVED. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK RICE CREEK MANUFACTURING 8617L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8703W, LOT# L54366