BEUDAMED
    FDA Adverse Event Death Summary report: N

    ITREVIA 7 DR-T DF4

    MDR report key: 8613265 · Received May 15, 2019

    Report

    Report Number
    1028232-2019-01963
    Event Type
    Death
    Date Received
    May 15, 2019
    Date of Event
    May 10, 2019
    Report Date
    May 14, 2019
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    UDI-DI
    04035479128944
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND ANALYZED. THE MEMORY CONTENT OF THE ICD WAS INSPECTED, SHOWING A NORMAL DEVICE FUNCTION WHILE IMPLANTED AND IN SERVICE. IN A NEXT STEP, A SENSING TEST WAS PERFORMED AND THE DEVICE SENSED THE ATTACHED HEART SIGNALS FREE OF NOISE. THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE NORMAL IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. A FIBRILLATION SIGNAL WAS APPLIED AND THE DEVICE DELIVERED A DEFIBRILLATION SHOCK AS SPECIFIED, DOCUMENTING A CORRECT SENSING AND SHOCK DELIVERY. IN PARTICULAR, THE SPECIFIED ENERGY LEVEL WAS REACHED. IN CONCLUSION, THE DEVICE PROVED TO BE FULLY FUNCTIONAL. THE ANALYSIS OF THE MEMORY CONTENT SHOWED A NORMAL DEVICE BEHAVIOR WHILE THE DEVICE WAS IMPLANTED AND IN SERVICE. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    PATIENT EXPIRED AT HOME. THE FAMILY IS QUESTIONING THE FUNCTIONALITY OF THIS ICD. THE MEDICAL EXAMINERS OFFICE SAY THEY WILL RETURN THE DEVICE TO THE MANUFACTURE FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407201 ITREVIA 7 DR-T DF4 ICD MRM BIOTRONIK SE & CO. KG 392426 04035479128944

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death