BEUDAMED
    FDA Adverse Event Death Summary report: N

    ITREVIA 7 HF-T QP DF4 IS4

    MDR report key: 6025970 · Received October 13, 2016

    Report

    Report Number
    1028232-2016-03647
    Event Type
    Death
    Date Received
    October 13, 2016
    Report Date
    September 15, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NIK
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    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 AND 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPIRED DUE TO CARDIOMYOPATHY BUT THE EXACT DATE IS UNKNOWN. THE PATIENT'S PHYSICIAN HAD NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676781 ITREVIA 7 HF-T QP DF4 IS4 CRT-D NIK BIOTRONIK SE & CO. KG 401662

    Patients

    Seq Age Sex Outcome Treatment
    1 Death