BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED EL

    MDR report key: 769908 · Received October 13, 2006

    Report

    Report Number
    6000030-2006-01700
    Event Type
    Death
    Date Received
    October 13, 2006
    Date of Event
    September 1, 2006
    Report Date
    September 21, 2006
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    p860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER NOTIFIED OF PATIENT'S DEATH. SEVERAL ATTEMPTS TO OBTAIN CAUSE OF DEATH HAVE BEEN MADE WITHOUT SUCCESS. WILL REQUEST DEATH CERTIFICATE. REF MFR REPORT# 6000032-2006-01698.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK LKK RICE CREEK MANUFACTURING 862718 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death CATHETER MODEL 8703W, LOT #L78427, IMPLANTED| EXPLANTED