BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3992347 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09924
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE FULL LEAD WAS RETURNED AND ANALYZED; ANALYSIS REVEALED THE DISTAL CONDUCTOR WAS DISTORTED DUE TO PULLING /STRETCHING/OVERSTRESS. SIMILAR DISTORTION WAS ALSO NOTED WITH THE PROXIMAL CONDUCTOR, AND INNER AND OUTER INSULATION. VISUAL ANALYSIS REVEALED THE LEAD WAS DAMAGED AT IMPLANT AND STRETCHED FROM ITS ORIGINAL LENGTH OF 45 CENTIMETERS (CM) TO 54.5 CM.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE PHYSICIAN NOTED "TIGHT ACCESS" WHEN PLACING THE RIGHT ATRIAL LEAD. WHEN THE LEAD WAS REMOVED TO "RESTICK", IT APPEARED DAMAGED. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472245 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR 6947M-62 LEAD