BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1020550 · Received March 28, 2008

    Report

    Report Number
    1028232-2008-00303
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    January 17, 2008
    Report Date
    February 28, 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 18 HOURS POST-IMPLANT, THIS DEXTRUS ATRIAL LEAD DISLODGED. IN A REVISION PROCEDURE, THE LEAD WAS SUCCESSFULLY REPOSITIONED. HOWEVER, THE PHYSICIAN STATED HE WAS DISSATISFIED WITH THE WAY THE LEAD WORKED WITH THE STYLET. NO ADVERSE PT EFFECTS WERE REPORTED. THE DATES OF IMPLANT AND EXPLANT ARE UNAVAILABLE.

    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 Hospitalization