BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE

    MDR report key: 1990034 · Received February 9, 2011

    Report

    Report Number
    MW5019398
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 28, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT AORTIC VALVE REPLACEMENT ON (B)(6) 2010 AND HAD AN UNEVENTFUL POSTOPERATIVE COURSE. A /FU TRANSTHORACIC ECHOCARDIOGRAM SUGGESTED MODERATE CENTRAL AORTIC VALVE INSUFFICIENCY. BLOOD CULTURES AND LAB TESTS SHOWED NO SIGN OF INFECTION. A REPEAT ECHO ON (B)(6) 2011 SHOWED MODERATE TO SEVERE CENTRAL AORTIC INSUFFICIENCY. IT WAS DECIDED TO REPLACE VALVE TO AVOID THE DEVELOPMENT OF ADHESIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE AORTIC VALVE LWQ ST. JUDE MEDICAL ESP100-23-00 A10321242

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention