BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIA DR-T

    MDR report key: 6669481 · Received June 27, 2017

    Report

    Report Number
    1028232-2017-02198
    Event Type
    Malfunction
    Date Received
    June 27, 2017
    Date of Event
    June 22, 2017
    Report Date
    June 22, 2017
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. THE RETURNED DEVICE DATA HAS BEEN ANALYZED. IN AGREEMENT WITH THE CLINICAL OBSERVATION, THE ANALYSIS REVEALED A LOWER BATTERY VOLTAGE THAN EXPECTED, HOWEVER, THE CURRENT CONSUMPTION WAS FOUND TO BE NORMAL. THE BATTERY STATUS ERI HAS BEEN REACHED SINCE (B)(6) 2017. 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. OF COURSE, INDIVIDUAL CIRCUMSTANCES AND MEDICAL JUDGEMENT DETERMINE DECISIONS ABOUT PATIENT CARE AND THE FREQUENCY OF FOLLOW-UP SESSIONS. THE ABOVE RECOMMENDATION IS BASED ON A PURELY TECHNICAL ASSESSMENT.

    Additional Manufacturer Narrative · 1

    THE PACEMAKER WAS RECEIVED FOR ANALYSIS. PRIOR TO THE ANALYSIS OF THE DEVICE, THE QUALITY DOCUMENTS ACCOMPANYING THE MANUFACTURING PROCESS FOR THIS PACEMAKER WERE REINVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. PARTICULARLY THE FINAL ACCEPTANCE TEST PROVED THE DEVICE FUNCTIONS TO BE AS SPECIFIED. UPON INITIAL INTERROGATION A WARNING MESSAGE WAS TRIGGERED REGARDING THE BATTERY CONDITION. THE BATTERY STATUS ERI WAS TRIGGERED ON (B)(6) 2017. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. THE INSPECTION REVEALED THAT THE BATTERY VOLTAGE DECREASED FASTER THAN EXPECTED. HOWEVER, THE CURRENT CONSUMPTION WAS NORMAL. AT A NEXT STEP THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTIBRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS AND IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. DURING SUBSEQUENT ANALYSIS THE PACEMAKER WAS OPENED AND SUBJECTED TO FURTHER INVESTIGATION. 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 ABNORMALITY. IN PARTICULAR THE CURRENT CONSUMPTION PROVED TO BE NORMAL AND EXPECTED. AT A NEXT STEP THE BATTERY WAS SENT TO THE MANUFACTURER FOR ANALYSIS. THE BATTERY WAS SUBJECTED TO A VISUAL AND AN ELECTRICAL INSPECTION, INCLUDING X-RAY AS WELL AS MICROCALORIMETRY ANALYSIS AND CONFIRMED THE BATTERY DEPLETION. THE DESTRUCTIVE ANALYSIS REVEALED THAT AN INTERNAL SHORT CIRCUIT WITHIN THE BATTERY CONTRIBUTED TO AN INCREASED INTERNAL SELF-DEPLETION AND THEREBY TO THE CLINICAL OBSERVATION. PLEASE NOTE THAT THE DEVICE WAS FULLY CAPABLE TO DELIVER ANTI-BRADYCARDIA THERAPY WHILE IMPLANTED AND IN SERVICE. BIOTRONIK MONITORS THE POST-MARKET PERFORMANCE OF ITS PRODUCTS CLOSELY IN ORDER TO IDENTIFY ANY TRENDS THAT MAY REVEAL OVER TIME A POTENTIAL MANUFACTURING OR DESIGN ISSUE. THE HISTORIC PERFORMANCE OF THE PRODUCT INVOLVED IN THE CURRENT CASE DOES NOT AT THIS POINT REVEAL ANY SUCH TREND.

    Description of Event or Problem · 1

    DEVICE LONGEVITY DECREASING FASTER THAN EXPECTED. RAM DUMP REQUESTED FOR ANALYSIS. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449871 EVIA DR-T PACEMAKER NVZ BIOTRONIK SE & CO. KG 359529

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR