BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2955661 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01336
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 15, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THE PROXIMAL CONDUCTOR WAS DISTORTED (PUL LED/STRETCHED/OVERSTRESS) AND THE DISTAL CONDUCTOR WAS FRACTURED DUE TO OVER-ROTATION. THE INNER INSULATION WAS BREACHED/TORN AND THE OUTER INSULATION WAS BREACHED/CUT. BLOOD WAS FOUND ON THE DISTAL END OF THE ELECTRODE, AND THE LEAD WAS FOUND TO BE STRETCHED AND DAMAGED AT IMPLANT.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, IT WAS NOT POSSIBLE TO POSITION THE RIGHT VENTRICULAR (RV) LEAD WITHOUT HIGH THRESHOLDS. ADDITIONALLY, AFTER MULTIPLE FIXATION ATTEMPTS, SIGNIFICANT NOISE WAS SEEN ON THE ANALYZER, WITHOUT ANY RESOLUTION, AND THE PHYSICIAN WAS NO LONGER ABLE TO ADVANCE A STYLET DOWN THE LUMEN OF THE LEAD. THE LEAD WAS NOT USED, AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, IT WAS NOT POSSIBLE TO POSITION THE RIGHT VENTRICULAR (RV) LEAD WITHOUT HIGH THRESHOLDS. ADDITIONALLY, AFTER MULTIPLE FIXATION ATTEMPTS, SIGNIFICANT NOISE WAS SEEN ON THE ANALYZER, WITHOUT ANY RESOLUTION, AND THE PHYSICIAN WAS NO LONGER ABLE TO ADVANCE A STYLET DOWN THE LUMEN OF THE LEAD. 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
    58456 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR