BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIA DR-T

    MDR report key: 9750657 · Received February 25, 2020

    Report

    Report Number
    1028232-2020-00883
    Event Type
    Malfunction
    Date Received
    February 25, 2020
    Date of Event
    February 19, 2020
    Report Date
    February 19, 2020
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    UDI-DI
    04035479101312
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE AS WELL AS THE RETURNED DEVICE DATA. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED AND ALL PRODUCTION STEPS WERE PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MAY BE RELATED TO THE CLINICAL OBSERVATION. THE RETURNED DATA HAVE BEEN ANALYZED. THE ANALYSIS REVEALED THAT THE CLINICAL OBSERVATION RESULTED FROM A BATTERY VOLTAGE LOWER THAN EXPECTED. HOWEVER, THE CURRENT CONSUMPTION WAS FOUND TO BE NORMAL. BASED ON THE INFORMATION AVAILABLE FOR ANALYSIS, THE ROOT CAUSE OF THIS OBSERVATION COULD NOT BE DETERMINED AND REQUIRES A DEVICE ANALYSIS. IT CANNOT BE EXCLUDED THAT THIS OCCURRENCE RESULTS FROM A COMPONENT DAMAGE LEADING TO A QUICKER DISCHARGE OF THE BATTERY. THEREFORE, IN ORDER TO EXCLUDE ANY POTENTIAL HARM FOR THE PATIENT WE WOULD LIKE TO RECOMMEND TO PRECAUTIONARY REPLACE THE DEVICE AND TO RETURN IT FOR ANALYSIS TO BIOTRONIK.

    Additional Manufacturer Narrative · 0

    THE PACEMAKER WAS RECEIVED FOR A DETAILED DEVICE ANALYSIS AND THE CLINICAL OBSERVATION WAS CONFIRMED. UPON RECEIPT, THE DEVICE WAS INTERROGATED REVEALING THE ERI BATTERY STATUS WHICH WAS TRIGGERED ON (B)(6) 2020. 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 IN ERI MODE. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. THE INSPECTION REVEALED THAT THE BATTERY VOLTAGE DECREASED FASTER THAN EXPECTED BUT MOST RECENT DOCUMENTED CURRENT CONSUMPTION MEASUREMENTS WERE NORMAL. THEREFORE, THE PACEMAKER WAS OPENED AND SUBJECTED TO FURTHER ANALYSIS. THE VISUAL INSPECTION OF THE INNER ASSEMBLY SHOWED NO ANOMALIES BUT THE BATTERY WAS FOUND TO BE ALMOST DEPLETED. THE BATTERY WAS DISCONNECTED FROM THE ELECTRONIC MODULE. FURTHER THOROUGH INVESTIGATION OF THE ELECTRONIC MODULE DID NOT SHOW ANY ANOMALIES. IN PARTICULAR THE CURRENT CONSUMPTION PROVED TO BE NORMAL AND EXPECTED. THE BATTERY WAS SENT TO THE MANUFACTURER FOR ANALYSIS. THE MANUFACTURING PROCESS FOR THE BATTERY WAS RE-INVESTIGATED AND ALL PRODUCTION STEPS WERE PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MAY BE RELATED TO THE CLINICAL OBSERVATION. SUBSEQUENTLY THE BATTERY WAS SUBJECTED TO A VISUAL AND AN ELECTRICAL INSPECTION, INCLUDING X-RAY AS WELL AS MICROCALORIMETRY ANALYSIS AND CONFIRMED AN ALMOST DEPLETED BATTERY. HOWEVER, THE DESTRUCTIVE ANALYSIS DID NOT REVEAL ANY ABNORMALITY WHICH MIGHT HAVE LED TO AN EARLY DEPLETION OF THE BATTERY. IN SUMMARY, THE PACEMAKER WAS IMPLANTED FOR 96 MONTHS. DESPITE THE COMPREHENSIVE ANALYSIS, THE ROOT CAUSE FOR THE CLINICAL OBSERVATION COULD NOT BE DETERMINED. A TEMPORARY HIGH CURRENT CONDITION CANNOT BE COMPLETELY EXCLUDED. HOWEVER, THE ANALYSIS OF THE ELECTRONIC MODULE AS WELL AS OF THE BATTERY DID NOT SHOW ANY ABNORMALITIES. THE THERAPY FUNCTIONALITY OF THE PACEMAKER WAS NOT COMPROMISED WHILE IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    THIS IS THE PATIENT THAT PREVIOUSLY REPORTED THAT CM SMART COULD NOT SEND DATA EVEN THOUGH BLUE LIGHT WAS ON (B)(6) 2020. THEN, CM SMART WAS REPLACED WITH A NEW ONE ((B)(4)), BUT IT WAS REPORTED AGAIN BY A DOCTOR THAT THE DATA WAS STILL NOT SENT ON (B)(6) 2020 (AT THIS MOMENT, CM DATA WAS NOT SENT FOR 60 DAYS). THE REP VISITED THE PATIENT HOME, AND HE INTERROGATED USING A WAND, THEN SHOWED AN ERROR MESSAGE READING BATTERY ERROR DETECTED, PERFORM A MEMORY DUMP AND CONTACT BIOTRONIK. ALSO, THE REP CONFIRMED THAT IT BECAME ERI WHEN HE PERFORMED MEMORY DUMP. THE HP FOLLOWUP WAS DONE ON (B)(6) 2019 WITH NORMAL RESULTS. FOR 6 YEARS OF USE, THE BATTERY REMAINED AT 50 PERCENT. ON DEC. 2019, 45 PERCENT BATTERY REMAINED. THE DEVICE WAS EXPLANTED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215327 EVIA DR-T PACEMAKER NVZ BIOTRONIK SE & CO. KG 359529 04035479101312

    Patients

    Seq Age Sex Outcome Treatment
    1