BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL EVOLUTION

    MDR report key: 2000867 · Received February 17, 2011

    Report

    Report Number
    2182269-2011-00027
    Event Type
    Injury
    Date Received
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST. JUDE MEDICAL, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER ANGIO-SEAL DEPLOYMENT, WHILE THE PT WAS IN BED RECOVERING, A PAINFUL MUSCLE SPASM OCCURRED. THE PT WAS GIVEN PAIN MEDICATION (TYPE AND DOSE UNK) FOR THE PAIN. NO ADD'L INFO WAS AVAILABLE. THE IMPLANT DATE AND EVENT DATE ARE UNK, IT WAS REPORTED THAT THE INCIDENT HAPPENED SOMETIME BETWEEN (B)(6) 2010 AND (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL EVOLUTION ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL NA 3131963

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization