BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 2974007 · Received February 13, 2013

    Report

    Report Number
    1028232-2013-00240
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    September 29, 2012
    Report Date
    January 29, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    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 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 FROM A PHYSICIAN REGARDING AN EVALUATION DONE (B)(6). BOSTON SCIENTIFIC TECHNICAL SERVICES REVIEWED THE CHECK AND NOTED THAT THERE APPEARED TO BE LOW P-WAVE AMPLITUDE WITH INTERMITTENT ATRIAL UNDERSENSING ON THIS RIGHT ATRIAL LEAD. RA SENSITIVITY WAS REPROGRAMMED AND THE ISSUE APPEARED TO BE RESOLVED. ALSO, UPON REVIEW OF STORED ELECTROGRAMS THERE WAS AN EPISODE OF NOISE AND OVERSENSING SEEN. THE PHYSICIAN STATED THAT WAS DUE TO ELECTROCAUTERY AND THERE WAS NOT CONCERN REGARDING A LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64276 DEXTRUS 4135 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other