BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMONITOR 2-AF

    MDR report key: 9873860 · Received March 24, 2020

    Report

    Report Number
    1028232-2020-01417
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Date of Event
    December 18, 2019
    Report Date
    December 18, 2019
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR ANALYSIS. PRIOR TO THE ANALYSIS OF THE DEVICE, THE QUALITY DOCUMENTS ACCOMPANYING THE MANUFACTURING PROCESS FOR THIS DEVICE WERE RE-INVESTIGATED. ALL PRODUCTION STEPS WERE PERFORMED ACCORDINGLY, AND IN PARTICULAR THE FINAL ACCEPTANCE TEST PROVED THE DEVICE FUNCTIONS TO BE AS SPECIFIED. THE BIOMONITOR 2-AF COULD NOT BE INTERROGATED, THUS CONFIRMING HE CLINICAL OBSERVATION. THEREFORE THE DEVICE WAS OPENED AND SUBJECTED TO FURTHER INVESTIGATION. THE VISUAL INSPECTION OF THE INNER ASSEMBLY SHOWED NO ANOMALIES. THE MEASUREMENT OF THE BATTERY VOLTAGE CONFIRMED A DEPLETED BATTERY. IN A NEXT STEP, THE BATTERY WAS DISCONNECTED FROM THE ELECTRONIC MODULE. FURTHER THOROUGH INVESTIGATION OF THE ELECTRONIC MODULE DID NOT SHOW ANY ANOMALIES. IN PARTICULAR THE CURRENT CONSUMPTION PROVED TO BE NORMAL AND EXPECTED. THE BATTERY WAS SENT TO THE MANUFACTURER FOR FURTHER ANALYSIS. THE MANUFACTURING RECORDS OF THE BATTERY WERE INSPECTED, DOCUMENTING THAT THE BATTERY PARAMETERS WERE WITHIN SPECIFICATION DURING THE MANUFACTURING. NO ANOMALIES WERE DOCUMENTED DURING THE PRODUCTION PROCESS, ASSOCIATED WITH THIS BATTERY. THE BATTERY WAS SUBJECTED TO A VISUAL AND AN ELECTRICAL INSPECTION AS WELL AS A MICROCALORIMETRY ANALYSIS. THE VISUAL INSPECTION OF THE BATTERY DID NOT REVEAL ANY EXTERNAL SIGNS OF DAMAGE. THE MEASUREMENT OF THE BATTERY VOLTAGE CONFIRMED A DEPLETED BATTERY AND THE MICROCALORIMETRY ANALYSIS SHOWED A NORMAL HEAT DISSIPATION. IN A NEXT STEP, THE BATTERY WAS OPENED FOR DESTRUCTIVE ANALYSIS. DURING ANALYSIS NO INTERNAL ELECTRICAL SHORT WAS EVIDENT. HOWEVER, THE OCCURRENCE OF A TEMPORARY SHORT CIRCUIT THAT CONTRIBUTED TO AN INCREASED INTERNAL SELF-DEPLETION CANNOT BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    WE RECEIVED YOUR EVENT DESCRIPTION FOR THE ABOVE MENTIONED DEVICE AND WOULD LIKE TO THANK YOU FOR SUPPORTING OUR POST-MARKET SURVEILLANCE. AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS, THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE INFORMATION YOU PROVIDED HAS BEEN ENTERED INTO OUR QUALITY SYSTEM AS A COMPLAINT. THESE TYPES OF COMPLAINTS ARE USED TO EVALUATE SYSTEMS AND DEVICE PERFORMANCE THROUGHOUT OUR ORGANIZATION AND HELP TO MAINTAIN AND IMPROVE THE PERFORMANCE OF OUR DEVICES. SHOULD ADDITIONAL RELEVANT INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE, THE INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2019 THAT THIS DEVICE WAS REACHING ERI AFTER APPROXIMATELY 1 YEAR OF IMPLANT. PATIENT WAS BROUGHT IN FOR EVALUATION AND THE DEVICE WAS EXPLANTED ON (B)(6) 2020. UNCLEAR WHETHER THE DEVICE WAS ERI OR EOS; IT COULD NOT BE INTERROGATED TO CONFIRM. 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
    335371 BIOMONITOR 2-AF IMPLANTABLE CARDIAC MONITOR MXD BIOTRONIK SE & CO. KG 398493 04035479135522

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization