BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMONITOR 2-AF

    MDR report key: 5778526 · Received July 8, 2016

    Report

    Report Number
    1028232-2016-02255
    Event Type
    Injury
    Date Received
    July 8, 2016
    Date of Event
    April 22, 2016
    Report Date
    June 6, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MXD
    PMA / PMN Number
    K152995
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED YOUR COMPLAINT REGARDING THE ABOVE MENTIONED DEVICE AND WOULD LIKE TO THANK YOU FOR SUPPORTING OUR MARKET SURVEILLANCE. THE STERILIZATION OF THIS PRODUCT WAS CHECKED. THE BIOTRONIK STERILIZATION PROTOCOL CONFIRMED A REGULAR STERILIZATION. THE STERILIZATION PARAMETERS, SUCH AS GAS CONCENTRATION, TEMPERATURE, HUMIDITY, ETC., WERE WITHIN THE SPECIFIED VALUES. THIS WAS ALSO CONFIRMED BY THE MICROBIOLOGICAL INDICATORS THAT PROVED A SUCCESSFUL STERILIZATION. IF ADDITIONAL RELEVANT INFORMATION OR THE DEVICE ITSELF SHOULD BECOME AVAILABLE, PLEASE SEND THIS ALSO TO US. THE PROCESS WILL THEN BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    OUS MDR - THIS DEVICE WAS EXPLANTED DUE TO DEHISCENCE THAT LEAD TO THE DEVICE COMING OUT OF THE POCKET, CAUSING AN INFECTION. IT APPEARS THE PROVIDED EVENT AND EXPLANT DATES WERE REVERSED BECAUSE THEY ARE CHRONOLOGICALLY IMPOSSIBLE. THEREFORE, ONLY THE EVENT WILL BE REPORTED BASED ON THE DATE PROVIDED IN THE EVENT DESCRIPTION. THE DEVICE WAS EXPLANTED BUT NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432995 BIOMONITOR 2-AF ICM MXD BIOTRONIK SE & CO. KG 398493

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization