BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 2140911 · Received June 15, 2011

    Report

    Report Number
    1028232-2011-01261
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    April 22, 2011
    Report Date
    June 7, 2011
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. 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. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER WAS FEELING NAUSEOUS AND WEAK WHEN THEY PRESENTED TO THE HOSPITAL VIA AMBULANCE. THE PATIENT'S HEART RATE APPEARED TO HAVE PAUSES AND RATE AROUND 20 BPM RANGE WHILE BEING TRANSPORTED. A LOCAL SALES REPRESENTATIVE WAS PAGED TO CHECK THE DEVICE AND ALL FUNCTIONS AND LEAD MEASUREMENTS WERE NORMAL. THE SALES REPRESENTATIVE NOTED THE PATIENT HAD AUTO CAPTURE PROGRAMMED ON AND PACING AT AUTO 3.5V WITH THRESHOLDS AROUND .9V. WHEN THE DEVICE WAS CHECKED, THE OUTPUTS CHANGED TO 1.4V. THE PHYSICIAN WAS CONCERNED THERE MAY HAVE BEEN A LOSS OF CAPTURE ISSUE. THE SALES REPRESENTATIVE NOTED THE PATIENT HAD A NORMAL INTRINSIC WHEN SHE CHECKED THE DEVICE, HOWEVER PER THE PHYSICIAN'S PREFERENCE, PROGRAMMING CHANGES WERE MADE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention