BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4135

    MDR report key: 3002704 · Received February 13, 2013

    Report

    Report Number
    1028232-2013-00262
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    December 5, 2012
    Report Date
    January 30, 2013
    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

    OUS MDR - 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 - AFTER AN IMPLANT DURATION OF ABOUT 34 MONTHS, PACING INHIBITION ACCOMPANIED BY OVERSENSING ON THIS RIGHT VENTRICULAR LEAD WERE REPORTED. NO FRACTURE COULD BE SEEN VIA X-RAY. A NEW RV LEAD WAS GOING TO BE IMPLANTED BUT THE VEIN WAS OCCLUDED, THUS A NEW DEVICE AND LEAD WERE IMPLANTED WHILE THE OLD LEAD AND DEVICE REMAINED IN AND PROGRAMMED TO VVI. NO ADVERSE PT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63982 DEXTRUS 4135 PACER LEAD NVZ BIOTRONIK SE & CO KG 360308

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization