BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1131962 · Received August 21, 2008

    Report

    Report Number
    1028232-2008-00994
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    June 3, 2008
    Report Date
    July 25, 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 (BSC) CRM RECEIVED INFO THAT THIS PT WAS SEEN IN THE CLINIC ONE MONTH POST THE IMPLANT PROCEDURE. THE PHYSICIAN NOTED LOSS OF CAPTURE IN THE VENTRICLE WITH THIS RIGHT VENTRICULAR (RV) LEAD 4136/28258573. INTERMITTENT CAPTURE WAS ALSO NOTED IN THE ATRIUM WITH THE RIGHT ATRIAL (RA) LEAD. THE PHYSICIAN NOTED THE PT WAS EXHIBITING SIGNIFICANT ECTOPY. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REPOSITION BOTH THE RA 4135 AND RV 4136 LEADS AND THEY CURRENTLY REMAIN IN SERVICE. THE PHYSICIAN NOTED THE RV LEAD 4136 HAD MOVED SLIGHTLY SINCE THE ORIGINAL IMPLANT PROCEDURE.

    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