BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 2170729 · Received July 12, 2011

    Report

    Report Number
    1028232-2011-01525
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    May 10, 2011
    Report Date
    July 1, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    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 RECEIVED INFO THAT THIS RIGHT ATRIAL (RA) LEAD WAS NOT SENSING THE PT'S P WAVE. IT WAS REPORTED THAT THE DROP IN P WAVE AMPLITUDE WAS SEEN SHORTLY AFTER IMPLANT. THE LEAD WAS REPORTED TO HAVE NON-FUNCTIONAL CAPTURE. THE LEAD WAS SUSPECTED TO HAVE MOVED. A LEAD REVISION PROCEDURE WAS PERFORMED WHERE THE LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE PT EFFECTS REPORTED. THE LEAD HAS BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization