BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1181464 · Received September 30, 2008

    Report

    Report Number
    6000030-2008-06208
    Event Type
    Death
    Date Received
    September 30, 2008
    Report Date
    September 3, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE PUMP AND CATHETER WERE RECEIVED FOR ANALYSIS; NO INFO WAS PROVIDED WITH THE RETURNED PRODUCTS. THE PT WAS LISTED AS EXPIRED IN THE MANUFACTURER'S DEVICE TRACKING SYSTEM. THE HCP DID NOT HAVE ANY INFO REGARDING THE CAUSE OR CIRCUMSTANCES OF THE PT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death CATHETER MODEL 8709 LOT#J10844R14| EXPLANTED| IMPLANTED| PROGRAMMER MODEL PROGRAMMER LOT#UNK