BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELOX ST 53

    MDR report key: 1379306 · Received May 7, 2009

    Report

    Report Number
    1028232-2009-00609
    Event Type
    Injury
    Date Received
    May 7, 2009
    Date of Event
    April 6, 2009
    Report Date
    April 16, 2009
    Manufacturer
    BIOTRONIK GMBH & CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THEREFORE, THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE WERE RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING PRODUCTION AND FINAL ACCEPTANCE TEST. 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

    PER BIOTRONIK PT TRACKING, THIS SYSTEM WAS REMOVED FOR INFECTION, AND REPLACED WITH ANOTHER BIOTRONIK SYSTEM. CYLOS DR-T, MDR 1028232-2009-00608.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX ST 53 PACER LEAD DTB BIOTRONIK GMBH & CO. 346366

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization