BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 2860133 · Received November 29, 2012

    Report

    Report Number
    1028232-2012-02971
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    September 26, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BIOTORNIK 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 PRODUCT 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 VENTRICULAR (RV) LEAD REVEALED A RISE IN PACING IMPEDANCES FROM 880 OHMS TO 1200 OHMS. A LOSS OF CAPTURE (LOC) AND PACING FAILURE WAS OBSERVED DURING LEAD TESTING. THE PHYSICIAN SUSPECTED A LOOSE SET SCREW. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REPOSITIONED AND REMAINS IN SERVICE. NO ADVERSE PT EFFECTS WERE REPORTED. 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
    1 DEXTRUS 4136 PACER LEAD NVZ BIOTORNIK SE & CO. KG 360310

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK