BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELUNA 8 DR-T PROMRI

    MDR report key: 10263880 · Received July 13, 2020

    Report

    Report Number
    1028232-2020-02819
    Event Type
    Malfunction
    Date Received
    July 13, 2020
    Date of Event
    June 12, 2020
    Report Date
    June 14, 2020
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    UDI-DI
    04035479131937
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE LEAD AND THE PACEMAKER UNDER COMPLAINT WERE RETURNED FOR ANALYSIS. AT FIRST, THE MANUFACTURING PROCESSES FOR THE LEAD AND THE PACEMAKER WERE RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESSES. IN PARTICULAR, THE FINAL ACCEPTANCE TEST OF THE PACEMAKER DID NOT SHOW ANY DEVIATIONS FORM THE TECHNICAL SPECIFICATIONS. SUBSEQUENTLY THE PRODUCTS WERE ANALYZED. ELUNA 8 DR (B)(6). BEFORE ANALYZING THE DEVICE ITSELF, THE RETURNED DATA OBTAINED PRIOR TO EXPLANTATION WERE EVALUATED. AS MENTIONED IN THE COMPLAINT DESCRIPTION, THE DATA SHOWED THAT INTERROGATION THROUGH RF-TELEMETRY WAS UNSUCCESSFULLY ATTEMPTED ON JUNE 12, 2020. HOWEVER, THE DEVICE COULD BE PROPERLY INTERROGATED NINE TIMES ON JUNE 12, 2020 USING THE PROGRAMMER HEAD (PGH). DESPITE SUCCESSFUL INTERROGATION WITH THE PGH, THE DATA SHOWED THAT IT WAS NOT POSSIBLE TO PERFORM TESTS OR RE-PROGRAM THE PACEMAKER, AS INDICATED IN THE COMPLAINT. ALSO THE LACK OF CHANNEL MARKERS WAS CONFIRMED FROM THE RETURNED PICTURE OF THE PROGRAMMER SCREEN. FURTHERMORE THE DEVICE STATISTICS INDICATED A TEMPORARY HIGH ATRIAL PACING RATE BASED ON THE DATA THE ROOT CAUSE OF THESE OCCURRENCES WAS NOT CONCLUSIVELY DETERMINABLE, HOWEVER, IT COULD NOT BE EXCLUDED THAT THEY MIGHT HAVE RESULTED FROM A TEMPORARY INCONSISTENCY IN THE DEVICE MEMORY CONTENT. SUBSEQUENTLY, THE PACEMAKER WAS SUBJECTED TO A THOROUGH ANALYSIS. FIRST THE INTERROGATION CAPABILITY WAS TESTED AND THE PACEMAKER COULD BE SUCCESSFULLY INTERROGATED VIA RF-TELEMETRY AND USING THE PGH. AT A NEXT STEP THE DEVICE MEMORY CONTENT IN ITS CURRENT STATE WAS ANALYZED. NO NEW FINDINGS WERE OBTAINED REGARDING THE ROOT CAUSE OF THE OCCURRENCES MENTIONED ABOVE. THE DEVICE´S MEMORY CONTENT DID NOT SHOW ANY ANOMALIES. 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. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. THE CLINICALLY OBSERVED BEHAVIOR COULD NOT BE REPRODUCED. THEREFORE, AN ADDITIONAL LONG-TERM PACING TEST WAS INITIATED FOR FURTHER INSIGHTS. DURING THE TEST, WITH A RUNTIME OF OVER 30 DAYS, EVERY PACING PULSE WAS RECORDED AND EVALUATED IN DETAIL. NO ANOMALIES WERE DETECTED DURING THE ENTIRE TEST RUNTIME AND THE THERAPY FUNCTIONALITY OF THE DEVICE PROVED TO BE WITHIN SPECIFICATION. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. SUMMARY AND CONCLUSION: DESPITE THE COMPREHENSIVE DEVICE ANALYSIS NO DEFINITE CONCLUSION CAN BE DRAWN REGARDING THE ROOT CAUSE OF THE CLINICAL OBSERVATIONS. THE RETURNED DEVICE HAS BEEN FUNCTIONING PROPERLY DURING ANALYSIS AND THE REPORTED DEVICE BEHAVIOR COULD NOT BE REPRODUCED. AS NO HARDWARE DEVIATION WAS IDENTIFIED DURING DEVICE ANALYSIS, A TEMPORARY INCONSISTENT MEMORY CONTENT OF THE DEVICE COULD BE CONSIDERED TO BE CAUSAL FOR THE CLINICAL OBSERVATIONS. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM OR DESIGN WEAKNESS. THE ROOT CAUSE FOR THE TEMPORARY INCONSISTENT MEMORY CONTENT COULD NOT BE DETERMINED. BASED ON THIS ANALYSIS THE PRESENCE OF INVASIVE EXTERNAL INFLUENCES, SUCH AS STRONG ELECTROMAGNETIC FIELDS, MAY HAVE CONTRIBUTED TO THE OBSERVED BEHAVIOR.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION PERIOD OF APPROX. 26 MONTHS, IT WAS REPORTED THAT IT COULD NOT ESTABLISH RF TELEMETRY AND IT WAS NOT ABLE TO RUN TESTS OR CHANGE ANY PARAMETERS. FURTHERMORE IT WAS OBSERVED ON THE CHEST X-RAY THAT THE VENTRICULAR LEAD DISLODGED INTO THE ATRIUM. THE DEVICE AND THE LEAD WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730482 ELUNA 8 DR-T PROMRI PACEMAKER NVZ BIOTRONIK SE & CO. KG 394969 04035479131937

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization