BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIA DR-T

    MDR report key: 3193476 · Received June 27, 2013

    Report

    Report Number
    1028232-2013-01797
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    February 1, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACEMAKER AND THE LEAD WERE NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE, BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THESE PARTICULAR DEVICES AND THE RETURNED DEVICE DATA. THE MANUFACTURING PROCESS FOR THESE DEVICES WERE 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 WAS ANALYSED, PARTICULARLY THE PACEMAKER DUMP. THE PACEMAKER'S MEMORY CONTENT DOCUMENTED THAT ON (B)(6) 2013 THE LEAD IMPEDANCE MEASUREMENTS AMOUNTED TO 1100/1000 OHMS IN BIPOLAR AS WELL AS IN UNIPOLAR LEAD CONFIGURATION. IN CONTRAST, THE LEAD IMPEDANCE TREND OF THE FOLLOW-UP DATA DOCUMENTED A STABLE LEAD IMPEDANCE OF APPROXIMATELY 400 OHMS IN THE VENTRICLE. BASED ON ALL INFORMATION AVAILABLE THE ROOT CAUSE FOR THE CLINICAL OBSERVATION WAS NOT DETERMINABLE. HOWEVER, FURTHER INVESTIGATIONS DID NOT REVEAL ANY INDICATION OF A DEVICE MALFUNCTION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING. THE RETURNED DEVICE DATA WAS ANALYSED. THE ANALYSIS DID NOT REVEAL ANY INDICATION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    OUS MDR - ACCORDING TO HOME MONITORING DATA, THE V-LEAD IMPEDANCE (BI) HAD BEEN DOCUMENTED AROUND 400 OHMS. DURING A ROUTINE FOLLOW, THE V-LEAD IMPEDANCE WAS MEASURED AT 1100 OHM (BI). ALSO LOSS OF CAPTURE WAS FOUND AT 1.5V AND THRESHOLD WAS CHANGED TO 3.0V. ATM WAS ALSO CHANGED FROM ON TO OFF (PULSE WIDTH 1.0MS). THE V-LEAD IMPEDANCE WAS NOT MEASURED IN UNIPOLAR. DESPITE THE OBSERVED HIGH IMPEDANCE, THE FOLLOW UP WAS FINISHED WITHOUT FURTHER CHECK. AFTER THIS FOLLOW UP (ON (B)(6)), THE V-LEAD IMPEDANCE HAS BEEN AGAIN AROUND 400 OHMS AS SEEN BY HM DATA. HOWEVER, AFTER A WHILE, THE PHYSICIAN STARTED SAYING THAT THE SUDDEN IMPEDANCE CHANGES MIGHT INDICATE A MALFUNCTION OF EITHER THE PACEMAKER OR THE LEAD. AN ADDITIONAL FOLLOW UP WAS CARRIED OUT BECAUSE OF THIS ON (B)(6) 2013 AND NO ABNORMAL MEASUREMENT WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294823 EVIA DR-T PACEMAKER DXY BIOTRONIK SE & CO. KG 359529

    Patients

    Seq Age Sex Outcome Treatment
    1 Other