BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1020708 · Received March 24, 2008

    Report

    Report Number
    1028232-2008-00278
    Event Type
    Injury
    Date Received
    March 24, 2008
    Date of Event
    January 23, 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 ONE DAY POST IMPLANT, THE INTEGRITY OF THIS RIGHT ATRIAL (RA) LEAD WAS QUESTIONED. INITIALLY, ATRIAL IMPEDANCE MEASUREMENTS NOR MARKERS WERE OBTAINED. A SURFACE EKG INDICATED P-WAVE AMPLITUDES WERE PRESENT, WITH AN INTRINSIC RATE OF 80. HOWEVER, THE ATRIAL SENSING WAS INTERMITTENT TO UNDERSENSING, WITH A HIGH THRESHOLD MEASUREMENT, AND NO CAPTURE OBSERVED. A MAGNET APPLICATION ELICITED THE APPROPRIATE AP VP MARKERS, BUT THE TIMING WAS INAPPROPRIATE BECAUSE OF THE FAST PT RATE. FOLLOWING X-RAY, THE LEAD WAS COMPLETELY DISLODGED. IT WAS SUCCESSFULLY REPOSITIONED AND TESTED NORMAL THE NEXT DAY. THE PHYSICIAN BELIEVES IT WAS DUE TO THE FACT THAT THE PT HAD BYPASS AND HIS ANATOMY. TO DATE, NO ADVERSE PT 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 Hospitalization