BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILESTO 7 VR-T DX DF-1

    MDR report key: 5172471 · Received October 24, 2015

    Report

    Report Number
    1028232-2015-03890
    Event Type
    Death
    Date Received
    October 24, 2015
    Date of Event
    October 4, 2015
    Report Date
    October 8, 2015
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE DEVICE WAS INTERROGATED, REVEALING THE BATTERY STATUS BOS, 17 CHARGING CYCLES WERE RECORDED TO THE DEVICE MEMORY. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. THE INSPECTION REVEALED FOUR REGULAR VF DETECTIONS ON (B)(4) 2015 IN THE PERIOD OF 10:45 AM TO 10:49 AM DUE TO INTRINSIC SIGNALS. TWO OF THAT FOUR VF EPISODES WERE SUCCESSFULLY TERMINATED BY THE DEVICE AND TWO EPISODES SHOWED AN ABORT OF THE CHARGING CYCLE DUE TO RETURN TO A NORMAL SINUS RHYTHM AS SPECIFIED. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. IN A NEXT STEP, THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. FIRST, A SENSING TEST WAS PERFORMED AND THE DEVICE SENSED THE ATTACHED HEART SIGNALS FREE OF NOISE, PROVING THE SENSING FUNCTIONS OF THE ICD TO BE AS EXPECTED. FOLLOWING, 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. AFIBRILLATION 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 AND THE CHARGING TIME WAS NORMAL. IN CONCLUSION, THE DEVICE PROVED TO BE FULLY FUNCTIONAL. THE INSPECTION OF THE DEVICE DATA SHOWED A NORMAL AND AS EXPECTED DEVICE BEHAVIOR WHILE THE ICD WAS IMPLANTED AND INSERVICE. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THE PATIENT EXPIRED ON (B)(6) 2015 DUE TO A MOTORCYCLE ACCIDENT. THE MEDICAL EXAMINER WANTED AN ANALYSIS ON THE DEVICE TO SEE IF THERE WERE ANY CORRELATIONS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704112 ILESTO 7 VR-T DX DF-1 ICD LWS BIOTRONIK SE & CO. KG 383594

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death