BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMONITOR 2-AF

    MDR report key: 9792970 · Received March 5, 2020

    Report

    Report Number
    1028232-2020-01130
    Event Type
    Malfunction
    Date Received
    March 5, 2020
    Date of Event
    September 18, 2019
    Report Date
    September 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 · 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 RE-INVESTIGATED AND ALL PRODUCTION STEPS WERE PERFORMED ACCORDINGLY. THE DEVICE WAS INTERROGATED AND THE MEMORY CONTENT WAS ANALYZED REVEALING A NORMAL AND EXPECTED CURRENT CONSUMPTION, HOWEVER, AN INCONSISTENCY BETWEEN CURRENT CONSUMPTION AND BATTERY VOLTAGE WAS NOTED. 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. NEXT, 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. THE MICROCALORIMETRY ANALYSIS SHOWED NO ANOMALIES. NEXT, THE BATTERY WAS OPENED FOR DESTRUCTIVE ANALYSIS. THE INSPECTION OF THE INNER ASSEMBLY IDENTIFIED DAMAGED INSULATION, 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.

    Description of Event or Problem · 1

    THIS DEVICE WAS EXPLANTED DUE TO ERI. THE MANUFACTURERS ANALYSIS REVEALED A BATTERY ISSUE. 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
    254816 BIOMONITOR 2-AF IMPLANTABLE CARDIAC MONITOR MXD BIOTRONIK SE & CO. KG 398493 04035479135522

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization