BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTRONIK BIOMONITOR 3M LOOP RECORDER

    MDR report key: 11648041 · Received April 9, 2021

    Report

    Report Number
    MW5100682
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    February 11, 2021
    Report Date
    April 7, 2021
    Manufacturer
    BIOTRONIK INC.
    Product Code
    MXD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LOOP RECORDER IMPLANTED (B)(6) 2021 ON THE LEFT CHEST WALL. ON (B)(6) 2021 INTERROGATION OF DEVICE SHOWED SIGNIFICANT ARTIFACT AND CT OF CHEST SHOWED THE RECORDER MIGRATED TO THE LEFT COSTOPHRENIC SULCUS IN THE THORACIC CAVITY OR IN THE EXTRAPLEURAL SPACE. THORACIC SURGERY REQUIRED TO LOCATE AND REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541547 BIOTRONIK BIOMONITOR 3M LOOP RECORDER RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITH ARRHYTHMIA DETECTION) MXD BIOTRONIK INC. 450218

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R