BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC AP360

    MDR report key: 2082515 · Received April 26, 2011

    Report

    Report Number
    2134151-2011-00005
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 29, 2011
    Manufacturer
    MEDTRONIC ATS, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: THE DEVICE REMAINS IMPLANTED. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS VALVE MET ALL MFG SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THERE WERE NO ADVERSE PT EFFECTS REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS MECHANICAL VALVE WAS IMPLANTED AFTER THE USE BY DATE (UBD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AORTIC AP360 LWQ MEDTRONIC ATS, INC. 505DA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other