BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 1133070 · Received August 21, 2008

    Report

    Report Number
    1028232-2008-00977
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    April 25, 2008
    Report Date
    July 24, 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
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT FELL. BOTH THE DEXTRUS ATRIAL LEAD REQUIRED REPOSITIONING. THERE WAS NO INDICATION OF LEAD DAMAGE. IN A REVISION PROCEDURE, THE LEAS WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE 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 UNK Hospitalization