BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 4162448 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12770
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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, ANALYZED AND THE DISTAL CONDUCTOR OF THE LEAD WAS EXTRINSICALLY OVER-ROTATED. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT OF A RIGHT ATRIAL (RA) LEAD, THE HELIX WOULD NOT DEPLOY. THE RA 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
    639702 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5568-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR