BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC HEMODYNAMIC PLUS

    MDR report key: 214558 · Received February 26, 1999

    Report

    Report Number
    214558
    Event Type
    Injury
    Date Received
    February 26, 1999
    Date of Event
    February 22, 1999
    Report Date
    February 24, 1999
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT REQUIRED AORTIC VALVE REPLACEMENT. IN THE OR, THE MECHANICAL VALVE WAS SEWN INTO PLACE BUT FAILED TO OPEN. A SEPARATE VALVE WAS IMPLANTED. THE PT REMAINED IN THE INTENSIVE CARE UNIT POST OPERATIVELY AND EXPIRED 2/25/1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AORTIC HEMODYNAMIC PLUS Implant MECHANICAL HEART VALVE LWQ ST. JUDE MEDICAL, INC. 21AHPJ-505 *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other| R