BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 1021859 · Received March 28, 2008

    Report

    Report Number
    1028232-2008-00323
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 4, 2008
    Report Date
    March 3, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Product Problem
    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 WAS EXPLANTED. THERE WERE SEVERAL EPISODES OF LOSS OF CAPTURE THAT WERE UNABLE TO BE EXPLAINED BY DIAGNOSTIC TESTING. THE PT WAS COMPLETELY DEPENDENT. UPON EXPLANT, THE PHYSICIAN NOTED BLOOD IN THE HEADER. A NEW LEAD WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD DTB BIOTRONIK GMBH AND CO. 258754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization