BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1061698 · Received June 13, 2008

    Report

    Report Number
    6000030-2008-03235
    Event Type
    Injury
    Date Received
    June 13, 2008
    Report Date
    June 9, 2006
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. THE SERIAL NUMBER IS INCLUDED IN THE RANGE FOR THE SYNCHROMED EL PUMP MOTOR STALL DUE TO GEAR SHAFT WEAR MANUFACTURED BEGINNING SEPT. 1999 PHYSICIAN COMMUNICATION (DATED AUGUST 2007).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS NOT FUNCTIONING; BLACK "SLUDGE" WAS ASPIRATED FROM THE SAMPLING PORT. THERE WAS NO PT INJURY. NO PT SYMPTOMS WERE REPORTED. THE PUMP WAS EXPLANTED. THE PT STATUS AFTER PUMP EXPLANT WAS REPORTED AS "UNEVENTFUL". THE PUMP WAS USED TO DELIVER MORPHINE AND CLONIDINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention