BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIA DR-T

    MDR report key: 4231937 · Received November 6, 2014

    Report

    Report Number
    1028232-2014-003974
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    July 18, 2014
    Report Date
    October 27, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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 HAEMATOMA WAS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    THIS PATIENT DEVELOPED A HEMATOMA AND BRUISING POST IMPLANT OF THIS DEVICE. THE CAUSE WAS ATTRIBUTED TO THE USE OF AN ORAL ANTI-COAGULANT. NO NOTES AS TO WHAT ACTIONS WERE TAKEN TO RESOLVE THIS ISSUE, BUT IT WAS NOTED THE PATIENT CALLED THE OFFICE ON (B)(6) 2014 TO REPORT HE NO LONGER HAS ANY SIGNS OF THE BRUISING OR HEMATOMA. THIS DEVICE REMAINS ACTIVELY IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715568 EVIA DR-T PACEMAKER NVZ BIOTRONIK SE & CO. KG 359529

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other