BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 2872575 · Received December 7, 2012

    Report

    Report Number
    1028232-2012-03130
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    September 20, 2012
    Report Date
    November 23, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    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 ATRIAL LEAD WAS EXPLANTED ONE DAY POST IMPLANT DUE TO DISLODGEMENT. THE PHYSICIAN STATED HE THOUGHT THE LEAD TOO SHORT WHICH RESULTED IN THE DISLODGEMENT. NO ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4135 PACER LEAD DTB BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization