BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4162427 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12780
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 16, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. HOWEVER, THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD, THE HELIX OF THE LEAD WAS EXTRINSICALLY BENT AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE PHYSICIAN ATTEMPTED TO IMPLANT THE LEAD, AND THE HELIX MECHANISM FAILED. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639634 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR