BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILESTO 7 VR-T DX PROMRI DF-1

    MDR report key: 16781574 · Received April 20, 2023

    Report

    Report Number
    1028232-2023-02032
    Event Type
    Death
    Date Received
    April 20, 2023
    Date of Event
    April 12, 2023
    Report Date
    May 31, 2023
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EXPLANTED ON (B)(6) 2023 AND RETURNED TO MFG FOR EVALUATION. UPON RECEIPT, THE LEAD IMPLANTED WITH THE ICD WAS STILL CONNECTED TO THE ICD HEADER. THE CONNECTIONS BETWEEN THE LEAD AND THE DEVICE WERE TESTED, PROVING THAT THE LEAD WAS CONNECTED PROPERLY. PRIOR TO THE ANALYSIS OF THE DEVICES, THE MANUFACTURING PROCESSES FOR THE LEAD AND THE ICD WERE RE-INVESTIGATED. ALL PRODUCTION STEPS WERE PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING MANUFACTURING. PARTICULARLY THE FINAL ACCEPTANCE TESTS PROVED THE DEVICES FUNCTIONS TO BE AS SPECIFIED. THE LEAD AND THE ICD WERE DISCONNECTED FROM EACH OTHER AND SUBJECTED TO A THOROUGH ANALYSIS. ANALYSIS OF THE LEAD LINOX SMART PROMRI S DX 65/15 UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS FOUND CUT 15 CM DISTAL TO THE IS-1 CONNECTOR PIN. ONLY THE PROXIMAL FRAGMENT WAS RECEIVED FOR ANALYSIS. THE RETURNED LEAD FRAGMENT WAS VISUALLY AND ELECTRICALLY ANALYZED. THE VISUAL INSPECTION REVEALED THAT THE INSULATION WAS, APART FROM THE PRESENT CUT, FREE OF BREACHES. DURING THE ELECTRICAL ANALYSIS, THE DC RESISTANCES OF THE RECEIVED CONDUCTOR FRAGMENT WERE MEASURED. NO PECULIARITIES WERE FOUND. FURTHER ANALYSIS OF THE RETURNED LEAD FRAGMENT DID NOT REVEAL ANY IRREGULARITY THAT MIGHT HAVE CONTRIBUTED TO THE CLINICAL OBSERVATION. ANALYSIS OF THE ICD ILESTO 7 VR-T DX PROMRI DF-1 THE ICD WAS INTERROGATED, REVEALING THE MOS2 BATTERY STATUS. A TOTAL OF 40 CHARGING CYCLES WERE RECORDED IN THE DEVICES MEMORY. IN A NEXT STEP, 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 NORMAL AND EXPECTED SENSING AND SHOCK DELIVERY. IN PARTICULAR, THE SPECIFIED ENERGY LEVEL WAS REACHED. A SENSING TEST WAS PERFORMED. THE DEVICE SENSED THE ATTACHED HEART SIGNALS APPROPRIATELY, PROVING THE SENSING FUNCTION OF THE ICD TO BE NORMAL AND AS EXPECTED. SUBSEQUENTLY THE THRESHOLD MEASUREMENT FUNCTIONALITY OF THE ICD WAS TESTED SHOWING NO ANOMALIES. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. THERE WAS NO INDICATION OF AN ICD OR LEAD MALFUNCTION. TWO VF EPISODES WERE APPROPRIATELY DETECTED ON APRIL 12TH, 2023. EPISODE 180 AT 15:08, WHICH WAS TERMINATED BY ATP THERAPY AND EPISODE 181 AT 15:09. THE CHARGING OF A SHOCK DURING THE VF EPISODE 181 WAS STARTED, BUT IT WAS ABORTED BEFORE DELIVERY, DUE TO BRADYCARDIA DETECTION. THIS LED TO ANTI-BRADYCARDIA PACING THERAPY AT 40 BPM, AS PROGRAMMED. PLEASE NOTE, THE BRADYCARDIA DETECTION OCCURRED BECAUSE THE AMPLITUDE VALUES OF THE INTRINSIC HEART SIGNALS WERE PARTIALLY BELOW THE PROGRAMMED SENSING THRESHOLD OF 0.8 MV IN THE RIGHT VENTRICLE. THE IMPLANTED SYSTEM FUNCTIONED AS EXPECTED ACCORDING TO THE PROGRAMMED PARAMETERS AND THE PATIENTS INTRINSIC HEART SIGNALS. IN CONCLUSION, THE MEMORY CONTENT AS WELL AS THE THERAPEUTIC FUNCTIONALITY OF THE ICD WERE INSPECTED, SHOWING A NORMAL DEVICE BEHAVIOR. ANALYSIS DID NOT REVEAL ANY INDICATION OF AN ICD OR LEAD MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DIED SUDDENLY. SUSPICION OF UNDERSENSING DURING VENTRICULAR FIBRILLATION AND SHOCK THERAPY WAS INHIBITED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206222 ILESTO 7 VR-T DX PROMRI DF-1 ICD LWS BIOTRONIK SE & CO. KG 390094

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death