BEUDAMED
    FDA Adverse Event Death Summary report: N

    LORENZ PECTUS BAR

    MDR report key: 762427 · Received September 15, 2006

    Report

    Report Number
    762427
    Event Type
    Death
    Date Received
    September 15, 2006
    Date of Event
    August 7, 2006
    Report Date
    September 12, 2006
    Manufacturer
    W. LORENZ SURGICAL
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD DX OF PECTUS EXCAVATUM. NUSS BAR PLACED IN 2006. REVISION DONE THE FOLLOWING DAY FOR SLIPPED BAR. REVISION OF 1ST BAR AND PLACEMENT OF 2ND BAR 29 DAYS LATER . REVISION (BENDING) OF 2ND BAR TEN DAYS LATER . REMOVAL OF 1ST AND 2ND BARS 3 MONTHS LATER. "IMORED" AFTER REMOVAL OF 2ND BAR PT HAD CARDIAC ARREST. THOROCOTOMY SHOWED CAVITY FULL OF BLOOD. QUESTIONABLE TEAR IN HEART.

    Description of Event or Problem · 2

    DESCRIBE EVENT OR PROBLEM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LORENZ PECTUS BAR NUSS BAR HRS W. LORENZ SURGICAL * *
    2 LORENZ PECTUS BAR NUSS BAR HRS W. LORENZ SURGICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death
    2 17 YR