BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM REGENT HEART VALVE W/FLEX CUFF

    MDR report key: 1990065 · Received February 8, 2011

    Report

    Report Number
    2648612-2011-00013
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 4, 2011
    Report Date
    February 8, 2011
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC. (CS)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THIS 23 MM VALVE WAS EXPLANTED APPROX SIX YEARS POSTOPERATIVELY AND REPLACED WITH A SMALLER 19 MM SJM MECHANICAL VALVE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM REGENT HEART VALVE W/FLEX CUFF REGENT ROTATABLE VALVE LWQ ST. JUDE MEDICAL PUERTO RICO, INC. (CS) 23AGFN-756

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R