BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1162124 · Received September 16, 2008

    Report

    Report Number
    6000030-2008-05769
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH THE PUMP AND CATHETER WERE RETURNED TO THE MFR FOR ANALYSIS WHICH WAS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN DEVICE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS NOT RECEIVING A REDUCTION OF THEIR PAIN SYMPTOMS FOR AN UNK LENGTH OF TIME. THE PT IS REPORTEDLY INTROVERTED. DURING A REPLACEMENT OF THE PUMP, THE CATHETER WAS FOUND TO HAVE COME OUT OF THE INTRATHECAL SPACE. A MECHANICAL COMPLICATION WAS ALSO NOTED (UNSPECIFIED). THE DRUG USED IN THE PUMP WAS A MIXTURE OF FENTANYL, BUPIVICAINE, BACLOFEN AND DILAUDID. THE CONCENTRATION WAS 10,000 MCG/ML AT A DOSE OF 500 MCG/DAY. THE CONCENTRATION OF BACLOFEN WAS 50 MCG/ML. FOLLOWING THE REPLACEMENT OF PUMP AND CATHETER THE DRUG USED IN THE PUMP WAS CHANGED TO ONLY FENTANYL 6,369 MCG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention CATHETER MODEL 8709 LOT# N084793024 IMPLANTED| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNK