BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1953835 · Received January 4, 2011

    Report

    Report Number
    6000030-2011-00047
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    August 4, 2010
    Report Date
    December 10, 2010
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 18CC OF MEDICATION WAS ASPIRATED FROM THE PUMP WHEN IT WAS SUPPOSED TO BE EMPTY. THE PUMP WAS ALARMING. THE PUMP WAS REPLACED DUE TO END OF LIFE. THE PT RECOVERED. DILAUDID AND BUPIVICAINE WERE USED IN THE PUMP. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention CATHETER: MODEL 8709, LOT# J11487R60| EXPLANTED:| IMPLANTED: