BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1133046 · Received August 21, 2008

    Report

    Report Number
    1028232-2008-00988
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    April 18, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD DISLODGED TWICE. THE PHYSICIAN ELECTED TO REPLACE THE LEAD WITH A NEW NON-BSC MANUFACTURED LEAD. THE PHYSICIAN NOTED THE PATIENT WAS IN ATRIAL FIBRILLATION. NO ADVERSE PATIENT 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 UNK Hospitalization