BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1020535 · Received March 28, 2008

    Report

    Report Number
    1028232-2008-00297
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    January 14, 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 THE PT WITH THIS DEVICE EXPERIENCED A SYNCOPAL EPISODE THAT RESULTED IN A HEAD INJURY. THE PHYSICIAN REVISED THE RIGHT VENTRICULAR (RV) LEAD DUE TO EXIT BLOCK. IT WAS BELIEVED THAT THE HEART TISSUE WAS THE CAUSE OF THE EXIT BLOCK AS THE LEAD WAS FIRMLY ATTACHED TO THE TISSUE. THE LEAD WAS SUCCESSFULLY REVISED.

    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