BEUDAMED
    FDA Adverse Event Death Summary report: N

    ITREVIA 7 HF-T QP DF4 IS4

    MDR report key: 6120856 · Received November 22, 2016

    Report

    Report Number
    1028232-2016-04662
    Event Type
    Death
    Date Received
    November 22, 2016
    Date of Event
    September 30, 2016
    Report Date
    November 14, 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
    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 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.

    Description of Event or Problem · 1

    WE WERE NOTIFIED BY THE PATIENTS FAMILY THAT THIS PATIENT EXPIRED ONE WEEK AFTER THE ICD SYSTEM WAS IMPLANTED. THE FAMILY NOTED THAT THIS DEVICE DELIVERED 3 SHOCKS THE DAY AFTER IMPLANT AND THAT THERAPY WAS TURNED OFF 3 DAYS AFTER SURGERY BECAUSE THE MEDICATION THE PATIENT WAS ON AND THE DEVICE WERE TOO MUCH FOR THE PATIENTS BODY. THE FAMILY BELIEVES THAT THIS DEVICE WAS EXPLANTED BEFORE THE PATIENT WAS CREMATED. THIS DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773359 ITREVIA 7 HF-T QP DF4 IS4 CRT-D NIK BIOTRONIK SE & CO. KG 401662

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death