BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEXOS DR-T

    MDR report key: 1020530 · Received March 28, 2008

    Report

    Report Number
    1028232-2008-00285
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    January 23, 2008
    Report Date
    February 28, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LPQ
    PMA / PMN Number
    900009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER CALL TO REP. THIS DEVICE WAS REMOVED BECAUSE OF ERI INDICATION AFTER AN IMPLANTATION TIME OF ABOUT 2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEXOS DR-T ICD LPQ BIOTRONIK GMBH AND CO. 347001

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization