BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1033744 · Received April 25, 2008

    Report

    Report Number
    1028232-2008-00451
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    February 19, 2008
    Report Date
    March 27, 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 APPROX TWO MOS FOLLOWING IMPLANT WITH THIS RIGHT VENTRICULAR (RV) LEAD, IT DISLODGED. IT WAS REPORTED THAT THE PT ANATOMY REQUIRED A LONGER LEAD. DURING THE REVISION PROCEDURE, THE LEAD INSULATION WAS PUNCTURED WITH NEEDLE TO GAIN ACCESS FOR INTRODUCER WIRE. THIS LEAD WAS EXTRACTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. TO DATE, NO ADVERSE PT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization