BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1142731 · Received August 26, 2008

    Report

    Report Number
    1028232-2008-01013
    Event Type
    Injury
    Date Received
    August 26, 2008
    Date of Event
    June 17, 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 CRM RECEIVED INFO THAT THIS RIGHT ATRIAL (RA) LEAD DISLODGED ONE DAY POST-IMPLANT. THE DISLODGEMENT WAS REVEALED AS THERE WAS NO SENSING OR CAPTURE. IT WAS STATED THAT THIS LEAD WAS DIFFICULT TO POSITION AND WAS NOT PERFORMING WELL AS FAR AS NUMBERS AND DISLODGEMENTS. THIS RA LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADVERSE PT EFFECTS HAVE BEEN 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