BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1220450 · Received November 4, 2008

    Report

    Report Number
    6000030-2008-07181
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 8, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE ER DUE TO A LOSS/DECREASE OF CONSCIOUSNESS. TROUBLESHOOTING WAS BEING CONSIDERED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 Hospitalization| R PROGRAMMER: MODEL PROGRAMMER| EXPLANTED:| CATHETER: MODEL 8709