BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 2627011 · Received June 18, 2012

    Report

    Report Number
    1028232-2012-01522
    Event Type
    Injury
    Date Received
    June 18, 2012
    Date of Event
    April 16, 2012
    Report Date
    June 5, 2012
    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 MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG 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 MFG.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED HIGH PACING THRESHOLDS. THE LEAD WAS OBSERVED TO HAVE DISLODGED. A REVISION PROCEDURE WAS PERFORMED. THE LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADD'L ADVERSE PT EFFECTS WERE REPORTED. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO., KG. 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization