BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMONITOR 2-AF

    MDR report key: 9623983 · Received January 23, 2020

    Report

    Report Number
    1028232-2020-00390
    Event Type
    Injury
    Date Received
    January 23, 2020
    Date of Event
    September 27, 2019
    Report Date
    January 17, 2020
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MXD
    UDI-DI
    04035479135522
    PMA / PMN Number
    K152995
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INFECTION WAS OBSERVED FOLLOWING THE IMPLANTATION OF THIS BIOTRONIK DEVICE. THE STERILIZATION PROCESS WAS INVESTIGATED. THE VALIDATED PROCESS ASSURES THAT ALL STERILIZATION PARAMETERS, SUCH AS GAS CONCENTRATION, TEMPERATURE, HUMIDITY, ETC., ARE WITHIN ITS SPECIFIED RANGES FOR EACH DISTRIBUTED DEVICE. ADDITIONALLY AN ANALYSIS OF VALIDATED MICROBIOLOGICAL INDICATORS IS PERFORMED AFTER EVERY STERILIZATION PROCEDURE AS EVIDENCE OF SUCCESSFUL COMPLETION OF THE STERILIZATION PROCESS. REVIEW OF THE BIOTRONIK COMPLAINT DATABASE DID NOT REVEAL ANY CHANGES REGARDING THE TREND FOR THIS TYPE OF INCIDENT. IN SUMMARY, THE INFECTION WAS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    THE PATIENT WAS DIAGNOSED WITH INFLAMMATION AND INFECTION AT THE IMPLANT SITE. NO ACTIONS WERE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83716 BIOMONITOR 2-AF IMPLANTABLE CARDIAC MONITOR MXD BIOTRONIK SE & CO. KG 398493 04035479135522

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization