BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYRA

    MDR report key: 413496 · Received August 29, 2002

    Report

    Report Number
    2184056-2002-00054
    Event Type
    Injury
    Date Received
    August 29, 2002
    Date of Event
    November 1, 2001
    Report Date
    August 29, 2002
    Manufacturer
    ANGEION CORP
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER 21 MONTHS OF IMPLANTATION, THIS ICD WAS EXPLANTED BECAUSE IT COULD NOT BE INTERROGATED. NOTE: ELA MEDICAL, INC. WAS NOT NOTIFIED OF THIS REMOVAL UNTIL 7/30/2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYRA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ANGEION CORP 2021 9923302A

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R