BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC AP

    MDR report key: 4871382 · Received June 26, 2015

    Report

    Report Number
    3008592544-2015-00024
    Event Type
    Injury
    Date Received
    June 26, 2015
    Date of Event
    May 5, 2015
    Report Date
    July 14, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS PATIENT AND EVENT HAVE BEEN UNSUCCESSFUL. THE DEVICE HAS NOT BEEN RETURNED. WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT ONE YEAR POST IMPLANT OF THIS MECHANICAL VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A MEDTRONIC BIOPROSTHETIC VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416124 AORTIC AP HEART-VALVE, MECHANICAL LWQ MEDTRONIC, INC. 505

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention