BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 1020717 · Received March 24, 2008

    Report

    Report Number
    1028232-2008-00267
    Event Type
    Injury
    Date Received
    March 24, 2008
    Date of Event
    December 13, 2007
    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 THIS RIGHT ATRIAL (RA) LEAD BECAME DISLODGED AND BEGAN TO PACE THE RIGHT VENTRICLE. AS A RESULT, THE RA LEAD WAS EXPLANTED. UPON EXPLANTING THE LEAD, A SMALL PIECE OF MYOCARDIUM WAS ATTACHED TO THE HELIX. A NEW RA LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4135 PACER LEAD DTB BIOTRONIK GMBH AND CO 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization