BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 1001929 · Received February 15, 2008

    Report

    Report Number
    1028232-2008-00094
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    September 6, 2007
    Report Date
    January 18, 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

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THEREFORE, THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR LEAD AND ALSO THE PRODUCTION LOT HAVE BEEN RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING PRODUCTION AND FINAL ACCEPTANCE TEST OF THIS LEAD AND THE PRODUCTION LOT. THE BIOTRONIK STERILIZATION PROTOCOL CONFIRMED THAT ALL STERILIZATION PARAMETERS, SUCH AS GAS CONCENTRATION, TEMPERATURE, HUMIDITY, ETC, WERE IN THEIR SPECIFIED RANGES. ALSO, THE INVESTIGATION OF THE MICROBIOLOGICAL INDICATORS SHOWED THE SUCCESSFUL COMPLETION OF THE STERILIZATION PROCESS. IN SUMMARY, THE INFECTION WAS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    BSC RECEIVED INFO THAT THIS IMPLANTABLE SYSTEM REMAINS IMPLANTED AT THIS TIME, PT HAD AN INFECTION. EXPLANT DATE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4135 PACER LEAD DTB BIOTRONIK GMBH AND CO 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization