BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMONITOR 2-AF

    MDR report key: 9876060 · Received March 24, 2020

    Report

    Report Number
    1028232-2020-01425
    Event Type
    Injury
    Date Received
    March 24, 2020
    Date of Event
    December 20, 2019
    Report Date
    March 10, 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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR ANALYSIS. THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE WERE RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING PRODUCTION AND FINAL ACCEPTANCE TEST. THE DEVICE AS RECEIVED WAS VISUALLY INSPECTED. THE VISUAL INSPECTION REVEALED NO EXTERNAL ANOMALIES. IN CONCLUSION THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    DEVICE WAS EXPLANTED DUE TO PATIENT COMPLAINTS OF PAIN. NO REPLACEMENT WAS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334303 BIOMONITOR 2-AF IMPLANTABLE CARDIAC MONITOR MXD BIOTRONIK SE & CO. KG 398493 04035479135522

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization