BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1033773 · Received April 25, 2008

    Report

    Report Number
    1028232-2008-00392
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    February 27, 2008
    Report Date
    March 25, 2008
    Manufacturer
    BIOTRONIK GMBH & 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

    BSC CRM RECEIVED INFO THAT THIS LEAD DISLODGED ONE DAY POST IMPLANT. THE PHYSICIAN NOTED TISSUE IN THE HELIX SO IT WAS REPLACED WITH A NEW LEAD. THERE WERE NOT ADVERSE PT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization