BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMONITOR 2-AF

    MDR report key: 6717463 · Received July 17, 2017

    Report

    Report Number
    1028232-2017-02489
    Event Type
    Injury
    Date Received
    July 17, 2017
    Date of Event
    July 12, 2017
    Report Date
    July 12, 2017
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MXD
    PMA / PMN Number
    K152995
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EROSION 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 CONCLUSION, THE EROSION WAS NOT DEVICE RELATED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THIS DEVICE WAS EXPOSED EXTERNALLY THROUGH THE POCKET. THIS DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498166 BIOMONITOR 2-AF ICM MXD BIOTRONIK SE & CO. KG 398493

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization