BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMONITOR 2-AF

    MDR report key: 15595059 · Received October 13, 2022

    Report

    Report Number
    1028232-2022-05256
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    January 20, 2021
    Report Date
    January 20, 2021
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MXD
    UDI-DI
    04035479135522
    PMA / PMN Number
    K152995
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE RECEIVED YOUR EVENT DESCRIPTION FOR THE ABOVE MENTIONED DEVICE. AS OF TODAY, THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. THE ANALYSIS IS THUS BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE AS WELL AS THE DATA RETURNED FOR EVALUATION. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED AND ALL PRODUCTION STEPS WERE PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS. PARTICULARLY THE FINAL ACCEPTANCE TEST PROVED THE DEVICE FUNCTIONS TO BE AS SPECIFIED. THE RETURNED DATA WERE THOROUGHLY INSPECTED. HOWEVER, THE ROOT CAUSE OF THE CLINICAL OBSERVATION WAS NOT DETERMINABLE BASED ON THE AVAILABLE INFORMATION. IT CANNOT BE EXCLUDED THAT A TEMPORARY BATTERY VOLTAGE DROP RESULTED IN THE DISPLAYED MESSAGE, AS MENTIONED IN THE COMPLAINT DESCRIPTION, TO ALERT THE USER IN A TIMELY MANNER. THE DATA DOCUMENTED THAT THE CURRENT CONSUMPTION OF THE DEVICE WAS NORMAL AND AS EXPECTED AND THE SENSING AND DETECTING FUNCTIONALITY WAS NOT COMPROMISED. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING. BASED ON THE INFORMATION AVAILABLE FOR ANALYSIS, THE DEFINITE ROOT CAUSE OF THE CLINICAL OBSERVATION WAS NOT DETERMINABLE. FOR A ROOT CAUSE INVESTIGATION AN ANALYSIS OF THE DEVICE ITSELF WOULD BE REQUIRED. SHOULD THE DEVICE BECOME AVAILABLE FOR ANALYSIS, THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 0

    THIS DEVICE WAS EXPLANTED DUE TO BATTERY ERROR MESSAGE AND ERI. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781039 BIOMONITOR 2-AF IMPLANTABLE CARDIAC MONITOR MXD BIOTRONIK SE & CO. KG 398493 04035479135522

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Hospitalization