BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMONITOR 2-AF

    MDR report key: 6830477 · Received August 30, 2017

    Report

    Report Number
    1028232-2017-03006
    Event Type
    Injury
    Date Received
    August 30, 2017
    Date of Event
    June 23, 2017
    Report Date
    August 17, 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

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    OUS MDR - THIS BIOMONITOR WAS EXPLANTED DUE TO A POSSIBLE INFECTION. A WHITE SPOT AND MILD REDNESS WERE OBSERVED NEAR THE IMPLANT SITE. THE SUTURES WERE REMOVED, POCKET WAS EMPTIED AND CLEANED. THERE IS NO REPLACEMENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610991 BIOMONITOR 2-AF ICM MXD BIOTRONIK SE & CO. KG 398493

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization