BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1000115 · Received February 19, 2008

    Report

    Report Number
    6000030-2008-00800
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    November 1, 2007
    Report Date
    January 24, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED NO ANOMALY FOUND - NORMAL DEVICE FUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S PUMP WAS REMOVED DUE TO INFECTION. NO PT SYMPTOMS WERE REPORTED. THE PUMP WAS USED TO DELIVER BACLOFEN. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention