BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC AP

    MDR report key: 1912633 · Received November 24, 2010

    Report

    Report Number
    2134151-2010-00011
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    MEDTRONIC ATS, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) . DEVICE HISTORY REVIEWED. RESULTS: OTHER = DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION : OTHER = CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: THE DEVICE HISTORY WAS REVIEWED AND SHOWED THAT THIS VALVE MET ALL MFG SPECIFICATIONS FOR PRODUCTS RELEASE FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MEDTRONIC ATS RECEIVED INFO THAT THE HEMODYNAMICS OF THIS MECHANICAL VALVE WERE NOT OPTIMAL AFTER VALVE IMPLANTATION. ANOTHER ATS VALVE WAS IMPLANTED AND THE HEMODYNAMICS WERE IMPROVED. NO ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AORTIC AP LWQ MEDTRONIC ATS, INC. 501DA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention