BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINOX SMART PROMRI SD 65/18

    MDR report key: 6067868 · Received October 31, 2016

    Report

    Report Number
    1028232-2016-04139
    Event Type
    Death
    Date Received
    October 31, 2016
    Date of Event
    September 22, 2016
    Report Date
    October 13, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD UNDER COMPLAINT WAS NOT RETURNED FOR ANALYSIS. THEREFORE THIS REPORT ONLY REFERS TO THE RESULTS OF THE ICD ANALYSIS. THE MEMORY CONTENT OF THE DEVICE WAS ANALYZED. IN AGREEMENT WITH THE CLINICAL OBSERVATION THE DATA REVEALED THAT THREE EPISODES WERE DETECTED BY THE ICD ON (B)(6) 2016. THE PROGRAMMED DETECTION ZONES VALID AT THAT TIME WERE: VT1 162BPM (370MS), ONSET: 20%, STABILITY: 24% NONE, VT2 188BPM (319MS), ONSET: 20%, STABILITY: 24% ATP, 2X BURST, 8X 40 J, VF 240BPM (250MS) BURST, 8X 40 J. THE FIRST EPISODE (EPISODE 17) AT 12:42 SHOWED AN APPROPRIATE DETECTION WITHIN THE PROGRAMMED VT1 MONITORING ZONE. AT 18:38 (EPISODE 18) THE PATIENT HAD A STABLE INTRINSIC RHYTHM IN THE VT2 THERAPY ZONE, THE RHYTHM WAS SUCCESSFULLY DETECTED AND ATP INITIATED BY THE ICD. THE TACHYCARDIA WAS THEREBY TERMINATED. AT 21:00 (EPISODE 19) THE DEVICE DETECTED ALL INTRINSIC SIGNALS AS EXPECTED, LEADING TO A SVT DETECTION DUE TO THE PROGRAMMED STABILITY CRITERION IN THE VT2 ZONE. IN NONE OF THE DOCUMENTED EPISODES UNDERSENSING WAS PRESENT. THE ICD DETECTED ALL SIGNALS AS EXPECTED. FURTHERMORE NO OTHER DEVICE DATA INDICATED A DEVICE MALFUNCTION. THE EXTERNAL ECG WAS ANALYZED SHOWING A RAPID VENTRICULAR RHYTHM AFTER THE DETECTION OF EPISODE 19 AFTER 21:00 O'CLOCK. DUE TO THE LACK OF A HIGH RESOLUTION TIME AXIS IN THE AVAILABLE ECG A DETERMINATION OF THE INTERVALS WITH A MILLISECOND ACCURACY IS NOT POSSIBLE. HOWEVER, THE INTERVAL OF THE DOCUMENTED RHYTHM WAS NOT SHORTER THAN ~390 MS, WHICH IS LONGER THAN THE LONGEST DETECTION INTERVAL OF 370 MS OF THE VT1 MONITORING ZONE THAT WAS PROGRAMMED AT THAT TIME. PLEASE NOTE THE LONGEST THERAPY INTERVAL AT THAT TIME WAS PROGRAMMED TO 319 MS. 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 NORMAL. SUBSEQUENTLY THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTIBRADYCARDIA 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 AND THE CHARGING TIME WAS AS EXPECTED. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE OBSERVED SYMPTOMS. PARTICULARLY THE FINAL ACCEPTANCE TEST PROVED THE DEVICE FUNCTIONS TO BE AS SPECIFIED. IN CONCLUSION, THE ANALYSIS OF THE DEVICE DATA REVEALED NO INDICATION OF A DEVICE MALFUNCTION. AN EXTENSIVE ANALYSIS OF THE ICD PROVED THE DEVICE TO BE FULLY FUNCTIONAL. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WITH THIS DEVICE IMPLANTED DIED. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE HIS HEART CONDITION. THE DEVICE DETECTED VENTRICULAR FIBRILLATION AND REACTED WITH APPROPRIATE THERAPY, BUT THE LAST EPISODE OF VENTRICULAR FIBRILLATION WAS BELOW THE PROGRAMMED THRESHOLD AND THEREFORE NOT RECOGNIZABLE BY THE DEVICE, NO THERAPY WAS DELIVERED. THE CLINICAL STAFF WAS MONITORING THE PATIENT ON AN EXTERNAL ECG, SO EXTERNAL SHOCKS WERE DELIVERED INSTEAD. THE PATIENT COULD NOT BE RESUSCITATED. THE DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719009 LINOX SMART PROMRI SD 65/18 ICD LEAD NVY BIOTRONIK SE & CO. KG 377170

    Patients

    Seq Age Sex Outcome Treatment
    1 Death