BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 2112266 · Received May 24, 2011

    Report

    Report Number
    1028232-2011-01149
    Event Type
    Injury
    Date Received
    May 24, 2011
    Report Date
    May 18, 2011
    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 - AFTER AN IMPLANT DURATION OF APPROX 3 WEEK MYOCARDIAL PERFORATION WAS REPORTED. THE LEAD WAS SUCCESSFULLY REPOSITIONED. THE DATE OF EVENT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4137 PACER LEAD NVZ BIOTRONIK SE & CO. KG, 360309

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization