BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2030404-2011-00274

    MDR report key: 2325377 · Received October 12, 2011

    Report

    Report Number
    2030404-2011-00274
    Event Type
    Malfunction
    Date Received
    October 12, 2011
    Date of Event
    August 15, 2011
    Report Date
    September 14, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    PMA / PMN Number
    K042775
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Male AGILIS INTRODUCER| ENSITE