BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILESTO 7 DR-T DF-1

    MDR report key: 10057271 · Received May 14, 2020

    Report

    Report Number
    1028232-2020-02027
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Date of Event
    January 17, 2020
    Report Date
    January 17, 2020
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    UDI-DI
    04035479125189
    PMA / PMN Number
    P050023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    METHOD, RESULT, AND CONCLUSION CODES WERE ADDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE ONLY BASED ON THE INSPECTION OF THE RETURNED DEVICE DATA. THE RETURNED DEVICE DATA HAVE BEEN INSPECTED. DURING THE INSPECTION, THE ERI BATTERY STATUS COULD BE CONFIRMED. THE BATTERY VOLTAGE OF THE DEVICE CORRESPONDS TO THE ERI STATUS, HOWEVER AN INCONSISTENCY OF BATTERY VOLTAGE AND CURRENT CONSUMPTION WAS NOTED. IN ORDER TO EXCLUDE ANY POTENTIAL HARM FOR THE PATIENT WE THEREFORE WOULD LIKE TO RECOMMEND TO REPLACE THE DEVICE AND TO RETURN IT FOR ANALYSIS TO BIOTRONIK. OF COURSE, INDIVIDUAL CIRCUMSTANCES AND MEDICAL JUDGMENT DETERMINE DECISIONS ABOUT PATIENT CARE. THE ABOVE RECOMMENDATION IS BASED ON A PURELY TECHNICAL ASSESSMENT. SHOULD ADDITIONAL RELEVANT INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE, THE INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE ONLY BASED ON THE INSPECTION OF THE RETURNED DEVICE DATA. THE RETURNED DEVICE DATA HAVE BEEN INSPECTED. DURING THE INSPECTION, THE ERI BATTERY STATUS COULD BE CONFIRMED. THE BATTERY VOLTAGE OF THE DEVICE CORRESPONDS TO THE ERI STATUS, HOWEVER AN INCONSISTENCY OF BATTERY VOLTAGE AND CURRENT CONSUMPTION WAS NOTED. IN ORDER TO EXCLUDE ANY POTENTIAL HARM FOR THE PATIENT WE THEREFORE WOULD LIKE TO RECOMMEND TO REPLACE THE DEVICE AND TO RETURN IT FOR ANALYSIS TO BIOTRONIK. OF COURSE, INDIVIDUAL CIRCUMSTANCES AND MEDICAL JUDGMENT DETERMINE DECISIONS ABOUT PATIENT CARE. THE ABOVE RECOMMENDATION IS BASED ON A PURELY TECHNICAL ASSESSMENT. SHOULD ADDITIONAL RELEVANT INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE, THE INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    ON (B)(6) 2019 THE DEVICE DISPLAYED NORMAL BATTERY STATUS OF 59 PERCENT. ON (B)(6) 2020 THE DEVICE ALERTED ERI VIA HOME MONITORING. THE PHYSICIAN WAS ADVISED TO TREAT AS ERI. DATA WAS ANALYSED AND ERI WAS CONFIRMED. THE DEVICE REMAINS IMPLANTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520686 ILESTO 7 DR-T DF-1 ICD MRM BIOTRONIK SE & CO. KG 383562 04035479125189

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR