BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 1020540 · Received March 28, 2008

    Report

    Report Number
    1028232-2008-00269
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    January 3, 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

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THIS RIGHT ATRIAL (RA) LEAD BECAME DISLODGED. UPON OPENING THE POCKET, IT WAS DISCOVERED THAT THE SUTURE SLEEVE WAS SEPARATED FROM THE SUTURE. TWO PIECES OF THE SUTURE SLEEVE WERE FOUND, HOWEVER, A THIRD PIECE WAS NOT FOUND AND REMAINS IN THE PT. THE RA LEAD WAS REPOSITIONED SUCCESSFULLY. A LEAD STABILIZER KIT WAS USED FOR A NEW SUTURE SLEEVE. NO ADVERSE PT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4135 PACER LEAD DTB BIOTRONIK GMBH AND CO. 3558744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization