BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1020706 · Received March 24, 2008

    Report

    Report Number
    1028232-2008-00280
    Event Type
    Injury
    Date Received
    March 24, 2008
    Date of Event
    January 24, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT DURING THE IMPLANT PROCEDURE, DIFFICULTY WAS EXPERIENCED POSITIONING THE 4136 LEAD IN THE ATRIUM. EVENTUALLY A GOOD POSITION WAS MAINTAINED WITH ACCEPTABLE THRESHOLDS, SENSING AND IMPEDANCE MEASUREMENTS. THE FOLLOWING DAY AT FOLLOW-UP, IT WAS NOTED THAT THERE WAS ATRIAL UNDERSENSING AND AN INCREASE IN PACING THRESHOLD. IN 2008, THE LEAD WAS NOTED TO HAVE COMPLETELY DISLODGED (FLUOROSCOPICALLY) AND THERE WAS AN ATTEMPT TO REPOSITION THE LEAD WITH VARIOUS STYLETS. THE LEAD CONTINUOUSLY DISLODGED ALTHOUGH THERE DID NOT SEEM TO BE A PROBLEM WITH EXTENSION AND RETRACTION OF THE HELIX.

    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