BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELOX JT 45

    MDR report key: 3031183 · Received April 2, 2013

    Report

    Report Number
    1028232-2013-00906
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT AND EXPLANT DATE HAVE BEEN CORRECTED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THEREFORE THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF 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

    THIS SYSTEM WAS REMOVED DUE TO (B)(6). CULTURES OF THE DEVICE AND LEADS SHOWED NO INFECTION. THERE IS NO INDICATION THAT THE SYSTEM WAS REPLACED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134371 SELOX JT 45 PACER LEAD NVN BIOTRONIK SE & CO. KG 346369

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization