BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOMONITOR 2-AF

    MDR report key: 6054035 · Received October 25, 2016

    Report

    Report Number
    1028232-2016-03903
    Event Type
    Death
    Date Received
    October 25, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 22, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MXD
    PMA / PMN Number
    K152995
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR ANALYSIS. PRIOR TO THE ANALYSIS OF THE DEVICE, THE QUALITY DOCUMENTS ACCOMPANYING THE MANUFACTURING PROCESS FOR THIS DEVICE WERE REINVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THE DEVICE COULD BE PROPERLY INTERROGATED. THE MEMORY CONTENT DOCUMENTED A NORMAL AND EXPECTED DEVICE BEHAVIOR WHILE IMPLANTED AND IN SERVICE. AT A NEXT STEP 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 VOLTAGE LOWER THAN EXPECTED. 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 TO 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 AND THE MICROCALORIMETRY ANALYSIS SHOWED NO ANOMALIES. THE ELECTRICAL INSPECTION CONFIRMED AN UNEXPECTED LOW VOLTAGE. IN A NEXT STEP, THE BATTERY WAS OPENED FOR DESTRUCTIVE ANALYSIS. DURING THE INSPECTION OF THE INNER ASSEMBLY OF THE BATTERY INSULATION DAMAGE WAS IDENTIFIED, WHICH LED TO AN ELEVATED INTERNAL SELF-DEPLETION WITHIN THE BATTERY AND THEREFORE CONTRIBUTED TO THE CLINICAL OBSERVATION. IN CONCLUSION, AN ELEVATED INTERNAL SELF-DEPLETION WITHIN THE BATTERY WAS FOUND TO BE THE ROOT CAUSE FOR THE CLINICAL OBSERVATION. BIOTRONIK WILL MONITOR CLOSELY IF COMPLAINTS RECEIVED IN FUTURE POINT TOWARDS A COMMON ROOT CAUSE. FOR THIS REASON WE ENCOURAGE CLOSE DIALOGUE BETWEEN CLINICIANS AND OUR PRODUCT EXPERTS IN ORDER TO EXPLORE ALL OPTIONS TO MINIMIZE ANY SUCH OCCURRENCES IN FUTURE.

    Description of Event or Problem · 1

    BERLIN HOME MONITORING CONTACTED TSV BECAUSE AN ERROR MESSAGE WAS SEEN REGARDING A POSSIBLE BATTERY ERROR. THEY REQUESTED THAT THE PATIENTS BE BROUGHT IN FOR A DEVICE INTERROGATION. PATIENT DIED FOR UNRELATED ISSUES PRIOR TO EXAMINATION OF THE IMPLANT. IT IS BELIEVED THE PATIENT PASSED AWAY ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705116 BIOMONITOR 2-AF ICM MXD BIOTRONIK SE & CO. KG 398493

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death