BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1133049 · Received August 21, 2008

    Report

    Report Number
    1028232-2008-00987
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    April 14, 2008
    Report Date
    July 24, 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 INFORMATION THAT THIS OEM MANUFACTURED TRANSVENOUS RIGHT ATRIAL (RA) LEAD HAD DISLODGED AFTER AN ARDUOUS INITIAL IMPLANT PROCEDURE. POOR SENSING OF ATRIAL FIBRILLATION WAS NOTED PRIOR TO THE DISLODGEMENT, AND THE PHYSICIAN HAD TROUBLE GETTING THE LEAD INTO TISSUE. THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOT TESTED AT IMPLANT DUE TO LOSS OF TELEMETRY, AND HAD TO BE REPROGRAMMED AT IMPLANT IN ORDER TO NOT TRACK ATRIAL FIBRILLATION AND TO OBTAIN R-WAVE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE 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| R