BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4137

    MDR report key: 3082853 · Received April 29, 2013

    Report

    Report Number
    1028232-2013-01096
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    February 26, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF 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 3 MONTHS LOSS OF CAPTURE ON THIS RIGHT VENTRICULAR LEAD WAS REPORTED. THE LEAD WAS NOT RETURNED FOR ANALYSIS. A REVISION PROCEDURE IS INTENDED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185663 DEXTRUS 4137 PACER LEAD NVN BIOTRONIK SE & CO. KG 358767

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization