BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 1133052 · Received August 21, 2008

    Report

    Report Number
    1028232-2008-00986
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    April 23, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE RIGHT ATRIAL (RA) LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED AND A NEW RA LEAD WAS SUCCESSFULLY IMPLANTED. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4135 PACER LEAD DTB BIOTRONIK, GMBH AND CO. 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization