BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 1131971 · Received August 21, 2008

    Report

    Report Number
    1028232-2008-00976
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    April 24, 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
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT DURING A CHECK OF THE ACUTE PACEMAKER (1290) AND RIGHT VENTRICULAR (RV) LEAD (4137), THERE WAS INTERMITTENT LOSS OF CAPTURE (LOC), HIGH THRESHOLDS, LOW IMPEDANCE MEASUREMENTS AND POOR SENSING. THE DEVICE WAS PROGRAMMED TO AUTOMATIC CAPTURE AND WAS IN RETRY MODE. A DEVICE ISSUE WAS SUSPECTED; HOWEVER, AFTER ADDITIONAL TESTING IT APPEARED THAT THE LEAD HAD DISLODGED. THE LEAD WAS REVISED (HELIX WAS EXTENDED) BUT THERE WAS STILL LOC AND POOR SENSING. THE DEVICE WAS EXPLANTED AND REPLACED. THE NEW DEVICE (1291) WAS TESTED AND THERE WAS CAPTURE SO THE POCKET WAS CLOSED. THEN LOC WAS OBSERVED AGAIN. THE POCKET WAS REOPENED AND THE RV LEAD WAS REPLACED WITH A NEW LEAD (4471). THERE WAS STILL LOC. THE PHYSICIAN DETERMINED THAT THE ISSUE WAS GLOBAL EXIT BLOCK AND LEFT THE NEW DEVICE AND LEAD IMPLANTED FOR THE TIME BEING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4137 PACER LEAD DTB BIOTRONIK GMBH AND CO. 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization