BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4135

    MDR report key: 2942101 · Received December 27, 2012

    Report

    Report Number
    1028232-2012-03468
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    October 1, 2012
    Report Date
    December 19, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    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 THIS PATIENT WAS BEING SEEN FOR NORMAL FOLLOW-UP. WHEN THE STORED ELECTROGRAMS FOR THE ATRIAL TACHY RESPONSE EPISODES WERE REVIEWED, IT WAS NOTED THAT THERE WAS NOISE AND OVERSENSING ON BOTH THE RIGHT ATRIAL LEAD AND RIGHT VENTRICULAR LEADS. MANY OF THE EPISODES OCCURRED AT NIGHT. THERE WAS NO ASYSTOLE SEEN BECAUSE THE PATIENT'S INTRINSIC RHYTHM CAME THROUGH. THE PATIENT NOTED SHE WAS HAVING FREQUENT COUGHING EPISODES AT NIGHT. ISOMETRICS AND ARM MOVEMENTS WERE PERFORMED AND THE NOISE WAS NOT ABLE TO BE REPRODUCED. LEAD MEASUREMENT WAS NORMAL AND STABLE. THE INFORMATION WAS REVIEWED WITH THE ELECTROPHYSIOLOGIST, AND SINCE THE NOISE WAS ON BOTH LEADS, ELECTROMAGNETIC INTERFERENCE WAS SUSPECTED. THE PLAN WAS TO RE-EVALUATE AGAIN IN THREE MONTHS AT A CLINIC APPOINTMENT. IT WAS REPORTED THAT THE PATIENT WAS ASYMPTOMATIC. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, 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 4135 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other