BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4137

    MDR report key: 1122177 · Received August 15, 2008

    Report

    Report Number
    1028232-2008-00902
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    May 9, 2008
    Report Date
    July 17, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO INCREASING THRESHOLD MEASUREMENTS, AND LOSS OF CAPTURE. THE PHYSICIAN ELECTED TO REPLACE THIS LEAD WITH A NEW NON-BSC RV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4137 PACER LEAD DTB BIOTRONIK GMBH AND CO. 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization