BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIA DR-T PROMRI

    MDR report key: 5192715 · Received October 30, 2015

    Report

    Report Number
    1028232-2015-03936
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 12, 2015
    Report Date
    October 19, 2015
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ALERT WITHIN THE HOME MONITORING SERVICES INFORMED US IN (B)(6) 2012 ABOUT AN UNREASONABLY HIGH CURRENT CONSUMPTION OF THE EVIA DR-T PACEMAKER MENTIONED ABOVE. TO PREVENT ANY HARM FOR THE PATIENT, BIOTRONIK RECOMMENDED TO SCHEDULE AN IN-OFFICE FOLLOW-UP TO VERIFY THE CURRENT CONSUMPTION, SINCE THE OBSERVED VALUES WOULD CONSIDERABLY DECREASE THE ESTIMATED SERVICE TIME OF THE DEVICE. UNDER SUCH CIRCUMSTANCES AN INFLUENCE ON THE THERAPY FUNCTIONS OF THE DEVICE CANNOT BE EXCLUDED AND THEREFORE A PRECAUTIONARY REPLACEMENT OF THE DEVICE WAS RECOMMENDED. FURTHERMORE, THE MEDICAL DEVICE SAFETY OFFICER VISITED THE HOSPITAL ON (B)(6) 2012 IN ORDER TO DISCUSS THIS CASE DIRECTLY. AT THE TIME, DEVICE DATA WERE COLLECTED AND SUBJECTED TO INSPECTION IN BIOTRONIK. THE DATA REVEALED A CURRENT CONSUMPTION OF 73 A WHICH, IF STABLE, WOULD LEAD TO A BATTERY EXHAUSTION WITHIN 19 MONTHS. BASED ON INDIVIDUAL CIRCUMSTANCES AND MEDICAL JUDGMENT, IT WAS DECIDED NOT TO EXPLANT THIS DEVICE BUT TO KEEP IT CLOSELY MONITORED, WHILE BIOTRONIK WOULD SEND REGULAR UPDATES REPORTING THE CURRENT BATTERY STATUS. DURING 2012, THE CURRENT CONSUMPTION WAS UNSTABLE AND WITH HIGH VALUES UP TO 110 A. SINCE END OF 2012 AND UNTIL END OF 2014 THE CURRENT CONSUMPTION RETURNED TO NORMAL AND STABLE VALUES AROUND 5.5 A. SINCE JANUARY 2015 THE CURRENT CONSUMPTION BECAME UNSTABLE AGAIN AND INCREASED TO VALUES AROUND 80 A, AS REPORTED LAST TIME IN (B)(6) 2015. AS OF TODAY, THE DEVICE DECLARED THE ERI STATUS AT THE BEGINNING OF (B)(6) 2015 AND WAS EXPLANTED IN (B)(6) 2015 AND RETURNED FOR ANALYSIS. AT THE TIME THE PACEMAKER WAS RUNNING AT ABOUT 32 A. THE PACEMAKER WAS RECEIVED FOR ANALYSIS AT THE END OF JANUARY 2016. PRIOR TO THE ANALYSIS OF THE DEVICE, THE QUALITY DOCUMENTS ACCOMPANYING THE MANUFACTURING PROCESS FOR THIS PACEMAKER WERE RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. PARTICULARLY THE FINAL ACCEPTANCE TEST PROVED THE DEVICE FUNCTIONS TO BE AS SPECIFIED. UPON RECEIPT, THE PACEMAKER WAS INTERROGATED SHOWING A WARNING MESSAGE ON THE PROGRAMMER INDICATING AN ELEVATED CURRENT CONSUMPTION. THEREFORE, THE PACEMAKER'S MEMORY CONTENT WAS ANALYZED CONFIRMING THIS OBSERVATION. THE BATTERY STATUS WAS ERI SINCE (B)(6) 2015. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS AND IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. THE THERAPY FUNCTIONALITY WAS STILL FULLY FUNCTIONAL. DURING THE ANALYSIS THE PACEMAKER WILL BE OPENED AND THE INNER ASSEMBLY OF THE DEVICE WILL BE CAREFULLY INSPECTED. AS OF TODAY, THE ANALYSIS IS ONGOING AND THEREFORE THE ROOT CAUSE OF THE CLINICAL OBSERVATION REMAINS UNKNOWN AT THIS POINT. THIS REPORT WILL BE UPDATED AS SOON AS THE ANALYSIS OF THE PACEMAKER HAS BEEN COMPLETED. PLEASE NOTE THAT THE THERAPY FUNCTIONS OF THE DEVICE WERE AVAILABLE AT ALL TIMES WHILE THE DEVICE WAS IMPLANTED AND IN SERVICE.

    Additional Manufacturer Narrative · 1

    AN INTERNAL WATCHDOG ALARM WITHIN THE HOME MONITORING SERVICES INFORMED US IN JULY 2012 ABOUT AN UNREASONABLY HIGH CURRENT CONSUMPTION OF THE EVIA DR-T PACEMAKER. TO PREVENT ANY HARM FOR THE PATIENT, BIOTRONIK RECOMMENDED TO SCHEDULE A TIMELY AND EXTRAORDINARY IN-OFFICE FOLLOW-UP TO VERIFY THE CURRENT CONSUMPTION, SINCE THE OBSERVED VALUES WOULD CONSIDERABLY DECREASE THE ESTIMATED SERVICE TIME OF THE DEVICE. UNDER SUCH CIRCUMSTANCES AN INFLUENCE ON THE THERAPY FUNCTIONS OF THE DEVICE CANNOT BE EXCLUDED AND THEREFORE A PRECAUTIONARY REPLACEMENT OF THE DEVICE WAS RECOMMENDED. FURTHERMORE, THE MEDICAL DEVICE SAFETY OFFICER VISITED THE HOSPITAL ON AUGUST 2012 IN ORDER TO DISCUSS THIS CASE DIRECTLY. AT THE TIME, DEVICE DATA WERE COLLECTED AND SUBJECTED TO INSPECTION IN BIOTRONIK. THE DATA REVEALED A CURRENT CONSUMPTION OF 73¿A WHICH, IF STABLE, WOULD LEAD TO A BATTERY EXHAUSTION WITHIN 19 MONTHS. BASED ON INDIVIDUAL CIRCUMSTANCES AND MEDICAL JUDGMENT, IT WAS DECIDED NOT TO EXPLANT THIS DEVICE BUT TO KEEP IT CLOSELY MONITORED, WHILE BIOTRONIK WOULD SEND REGULAR UPDATES REPORTING THE CURRENT BATTERY STATUS. DURING 2012, THE CURRENT CONSUMPTION WAS UNSTABLE AND WITH HIGH VALUES UP TO 110 ¿A. SINCE END OF 2012 AND UNTIL END OF 2014 THE CURRENT CONSUMPTION RETURNED TO NORMAL AND STABLE VALUES AROUND 5.5 ¿A. SINCE (B)(6) 2015 THE CURRENT CONSUMPTION BECAME UNSTABLE AGAIN AND INCREASED TO VALUES AROUND 80 ¿A, AS REPORTED LAST TIME IN(B)(6) 2015. AS OF TODAY, THE DEVICE DECLARED THE ERI STATUS AT THE BEGINNING OF (B)(6) 2015 AND WAS EXPLANTED IN (B)(6) 2015 AND RETURNED FOR ANALYSIS. AT THE TIME THE PACEMAKER WAS RUNNING AT ABOUT 32 ¿A. THE PACEMAKER WAS RECEIVED FOR ANALYSIS AT THE END OF (B)(6) 2016. PRIOR TO THE ANALYSIS OF THE DEVICE, THE QUALITY DOCUMENTS ACCOMPANYING THE MANUFACTURING PROCESS FOR THIS PACEMAKER WERE RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. PARTICULARLY THE FINAL ACCEPTANCE TEST PROVED THE DEVICE FUNCTIONS TO BE AS SPECIFIED. UPON RECEIPT, THE PACEMAKER WAS INTERROGATED SHOWING A WARNING MESSAGE ON THE PROGRAMMER INDICATING AN ELEVATED CURRENT CONSUMPTION. THEREFORE, THE PACEMAKER'S MEMORY CONTENT WAS ANALYZED CONFIRMING THIS OBSERVATION. THE BATTERY STATUS WAS ERI SINCE (B)(6) 2015.THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS AND IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. THE THERAPY FUNCTIONALITY WAS STILL FULLY FUNCTIONAL. DURING THE ANALYSIS THE PACEMAKER WAS OPENED. THE VISUAL INSPECTION OF THE INNER ASSEMBLY SHOWED NO ANOMALIES. SUBSEQUENT THOROUGH INVESTIGATIONS REVEALED A DAMAGED CAPACITOR, LEADING TO AN ELEVATED CURRENT CONSUMPTION DRAINING THE BATTERY. IN SUMMARY, THE CLINICAL OBSERVATION RESULTED FROM A DAMAGED CAPACITOR. THE MANUFACTURING RECORDS DOCUMENT A FLAWLESS DEVICE PRODUCTION, PARTICULARLY THE CURRENT CONSUMPTION WAS NORMAL AND EXPECTED. YET, THE DATE OF OCCURRENCE WAS NOT DETERMINABLE. PLEASE NOTE THAT THE THERAPY FUNCTIONS OF THE DEVICE WERE AVAILABLE AT ALL TIMES WHILE THE DEVICE WAS IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT ABOUT 46 MONTHS AFTER THE IMPLANTATION, ERI WAS NOTED. THE PACEMAKER REMAINS IMPLANTED AT THE MOMENT, BUT IT IS EXPECTED IT WILL BE EXPLANTED SOON. NO ADVERSE PATIENT SIDE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721299 EVIA DR-T PROMRI PACEMAKER NVZ BIOTRONIK SE & CO. KG 371996

    Patients

    Seq Age Sex Outcome Treatment
    1 Other