BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILIVIA 7 HF-T QP DF4 IS4 PROMRI

    MDR report key: 8939682 · Received August 28, 2019

    Report

    Report Number
    1028232-2019-03743
    Event Type
    Death
    Date Received
    August 28, 2019
    Date of Event
    July 25, 2019
    Report Date
    August 5, 2019
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NIK
    UDI-DI
    04035479142087
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT, THE DEVICE WAS INTERROGATED, REVEALING THE EOS BATTERY STATUS, 3600 CHARGING CYCLES WERE RECORDED IN THE DEVICES MEMORY. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. THE INSPECTION REVEALED, THAT THE ANTI-TACHYCARDIA THERAPY FUNCTIONS WERE NOT DEACTIVATED AFTER THE EXPLANTATION. AS A RESULT, NOISE WAS DETECTED AFTER EXPLANTATION, LEADING TO A LARGE AMOUNT OF CHARGING CYCLES. THE IEGMS CORRESPONDING TO THE TIME DURING WHICH THE DEVICE WAS IMPLANTED AND IN SERVICE WERE OVERWRITTEN BY THIS LARGE AMOUNT OF EPISODES. HOWEVER, THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. FURTHER, THE MEMORY CONTENT SHOWED, THAT THE EOS BATTERY STATUS OCCURRED ON 31-JAN-2020, MOST LIKELY RESULTING FROM MANY SUBSEQUENT CHARGING CYCLES IN A COLD TEMPERATURE ENVIRONMENT. IN A NEXT STEP, THE EOS STATUS WAS REMOVED WITH A TECHNICAL PROGRAMMER AND 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 NORMAL AND EXPECTED SENSING AND SHOCK DELIVERY. IN PARTICULAR, THE SPECIFIED ENERGY LEVEL WAS REACHED. IN CONCLUSION, THE DEVICE PROVED TO BE FULLY FUNCTIONAL. THE EOS STATUS WAS TRIGGERED AFTER THE EXPLANTATION OF THE DEVICE, MOST LIKELY DUE TO INFLUENCES OF A COLD TEMPERATURE ENVIRONMENT AND PROVED TO BE AS ANTICIPATED. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    DURING ICD IMPLANT PROCEDURE PATIENT HAD A RESPIRATORY ARREST LEADING TO CARDIAC ARREST AFTER PRE-PROCEDURE SEDATION. CPR WAS INITIATED FOR APPROX 15 MIN AND PATIENT WAS INTUBATED. BICARBONATE PUSHES AND VENTILATOR SETTINGS WERE MODIFIED. DOPAMINE AND NEOSYNEPHRINE WERE STARTED. ROSC OBTAINED AFTER APPROX 20 MINS. STABILIZED AND TRANSFERRED BACK TO THE UNIT. POST PROCEDURE, PATIENT DEVELOPED ACUTE ENCEPHALOPATHY, POSSIBLY SECONDARY TO ANOXIC BRAIN DAMAGE. PATIENT WAS TRANSITIONED TO COMFORT CARE ON (B)(6) 2019 AND WAS EXTUBATED. PATIENT PASSED AWAY ON (B)(6) 2019. EVENT WAS FIRST REPORTED (B)(6) 2019, BUT OPERATIVE NOTES CLARIFYING THE PROGRESSION AND SEVERITY OF EVENTS WERE NOT MADE AVAILABLE UNTIL (B)(6) 2019. NO COMPLAINTS REGARDING ANY COMPONENT OF THE SYSTEM HAVE BEEN REPORTED. ICD SYSTEM WAS SUCCESSFULLY IMPLANTED AND REMAINS IN THE BODY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736587 ILIVIA 7 HF-T QP DF4 IS4 PROMRI CRT-D NIK BIOTRONIK SE & CO. KG 404621 04035479142087

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death