BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 1142703 · Received August 26, 2008

    Report

    Report Number
    1028232-2008-01037
    Event Type
    Injury
    Date Received
    August 26, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 25, 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 SHORTLY AFTER BEING IMPLANTED, THIS LEAD MOVED TO DIFFERENT LOCATION IN THE RIGHT VENTRICLE. THE PHYSICIAN ELECTED TO REPOSITION THE LEAD BUT THE LEAD CONTINUED TO GO BACK TO ITS ORIGINAL POSITION AS THE PT DIDN'T HAVE AN APEX THAT WOULD ACCOMMODATE NORMAL POSITIONING. THE PHYSICIAN EXPLANTED THE LEAD AND REPLACED IT WITH A PASSIVE LEAD WHICH WAS STABLE. THE DISLODGED LEAD WAS DISCARDED.

    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