BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED EL

    MDR report key: 1071652 · Received July 9, 2008

    Report

    Report Number
    6000030-2008-03859
    Event Type
    Death
    Date Received
    July 9, 2008
    Date of Event
    May 8, 2006
    Report Date
    June 19, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED A NON-STANDARD NON-CONFORMANCE - A PUMP MEMORY ERROR WAS NOTED ON THE INITIAL PRINTOUT. THE PUMP WAS LEFT RUNNING IN SIMPLE CONTINOUS MODE FOR OVER TWO YEARS PRIOR TO RETURN FOR ANALYSIS. THE PUMP WAS USED TO DELIVER MORPHINE SULFATE. "SEE SCANNED PAGE".

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO THE MFR FROM AN UNKNOWN SOURCE WITH NO RETURN PAPERWORK. THE MFR'S DEVICE TRACKING SYSTEM INDICATED THAT THE PT EXPIRED. THE PHYSICIAN LISTED IN THE MFR'S DEVICE TRACKING SYSTEM FOR THE PT WAS CONTACTED TO TRY AND OBTAIN CAUSE OF DEATH AND DEVICE RELATIONSHIP. THE HCP STATED THEY WERE UNAWARE OF THE PT'S DEATH, SO THEY HAD NO INFO REGARDING CAUSE OF DEATH. THE PT WAS LAST SEEN BY THE HCP IN 2004 FOR A REFILL. FURTHER FOLLOW-UP IS NOT POSSIBLE DUE TO LACK OF ADDITIONAL CONTACT INFO.

    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 Death CATHETER MODEL 8703W| PROGRAMMER| EXPLANTED| IMPLANTED