BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1020711 · Received March 24, 2008

    Report

    Report Number
    1028232-2008-00275
    Event Type
    Injury
    Date Received
    March 24, 2008
    Date of Event
    January 19, 2008
    Report Date
    February 28, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT DURING A REVISION PROCEDURE, THE DEXTRUS ATRIAL LEAD WAS EXPLANTED DUE TO DISLODGEMENT AND THE DEXTRUS RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED DUE TO INTERMITTENT NON-CAPTURE AT MAX OUTPUTS. BOTH LEADS WERE SUCCESSFULLY REPLACED WITH NEW LEADS. NO ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD DTB BIOTRONIK GMBH AND CO 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization