BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 2974080 · Received February 13, 2013

    Report

    Report Number
    1028232-2013-00227
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    December 3, 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 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

    OUS MDR - BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE IMPLANTED WHILE THE PT WAS IN ATRIAL FIBRILLATION (AF); THEREFORE, COMPLETE TESTING OF THE LEADS HAD NOT BEEN PERFORMED. ONE MONTH LATER, ATRIAL AND VENTRICULAR UNDERSENSING WAS OBSERVED VIA HOLTER. P-WAVES WERE NOTED AT 0.2-0.4MV AND R-WAVES WERE NOTED AT 2.0-4.0MV. BOTH LEADS WERE REPOSITIONED, WITH IMPROVED P- AND R-WAVE VALUES. NO ADVERSE PT EFFECTS WERE REPORTED. THE PHYSICIAN BELIEVED THE SENSING ISSUE WAS DUE TO THE PT'S CONDITION AND WAS NOT CAUSED BY THE LEADS. BOTH LEADS REMAIN IMPLANTED. 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
    64254 DEXTRUS 4137 PACER LEAD NVZ BIOTRONIK SE & CO. KG 360314

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization