BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1201560 · Received October 16, 2008

    Report

    Report Number
    1028232-2008-01269
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    August 22, 2008
    Report Date
    September 16, 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 CRM RECEIVED INFORMATION THAT THIS VENTRICULAR LEAD HAD DISLODGED INTO THE ATRIUM. DURING THE REVISION, THE STYLET WAS UNABLE TO BE ADVANCED THROUGH THE LUMEN. THE PHYSICIAN ELECTED TO IMPLANT A NEW LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization