BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMONITOR 2-AF

    MDR report key: 6608500 · Received June 2, 2017

    Report

    Report Number
    1028232-2017-01813
    Event Type
    Injury
    Date Received
    June 2, 2017
    Date of Event
    May 16, 2017
    Report Date
    May 22, 2017
    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

    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. ADDITIONAL 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

    OUS MDR. IT WAS REPORTED THAT THIS DEVICE WAS EXPLANTED DUE TO POCKET INFECTION, DEHISCENCE OF THE POCKET, AND PRESSURE ULCERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389099 BIOMONITOR 2-AF ICM MXD BIOTRONIK SE & CO. KG 398493

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization