BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1142727 · Received August 26, 2008

    Report

    Report Number
    1028232-2008-01019
    Event Type
    Injury
    Date Received
    August 26, 2008
    Date of Event
    June 19, 2008
    Report Date
    July 25, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P9500037
    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 OEM MANUFACTURED TRANSVENOUS RIGHT ATRIAL (RA) LEAD WAS SUSPECTED TO HAVE DISLODGED. P-WAVE MEASUREMENTS WERE SOMETIMES LOW, AND VERY UNSTABLE. WHEN PACING IN AAI MODE, THE VENTRICLE APPEARED TO BE PACING. STORED ELECTROGRAMS SHOWED VENTRICULAR FIBRILLATION (VF) EVENTS ALIGNING WITH ATRIAL EVENTS AND ON THE SHOCK CHANNEL. TECHNICAL SERVICES CONCURRED THAT THIS WAS LIKELY A RA LEAD DISLODGEMENT, IN WHICH THE LEAD HAD FALLEN INTO THE RIGHT VENTRICLE OR WAS ON TOP OF THE TRICUSPID VALVE.

    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