BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 2042071 · Received March 29, 2011

    Report

    Report Number
    1028232-2011-00722
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    December 22, 2010
    Report Date
    March 15, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG.
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THIS PACING SYSTEM WAS EXPLANTED SECONDARY TO ENDOCARDITIS AND SUSPECTED INFECTION. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADD'L INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO. KG. 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization