BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1033751 · Received April 25, 2008

    Report

    Report Number
    1028232-2008-00455
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    February 21, 2008
    Report Date
    March 27, 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 (BSC) CRM RECEIVED INFORMATION THAT ONE DAY THE IMPLANT PROCEDURE, THIS RIGHT ATRIAL (RA) LEAD 4136 DISLODGED AND HAD NO CAPTURE. THE PHYSICIAN EXPLANTED THE 4136 LEAD AND REPLACED IT WITH A NEW RA LEAD 4470. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEADS DTB BIOTRONIK GMBH AND CO. 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization