BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2813140 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16977
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, THE PROXIMAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. VISUAL ANALYSIS NOTED THAT THE LEAD WAS RETURNED WITH BLOOD ON THE HELIX, NOT TISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, AN ATTEMPT WAS MADE TO FIXATE THE LEAD ON THE RIGHT VENTRICLE SEPTAL WALL. THE VALUES WERE INITIALLY GOOD, BUT WHEN TESTED VIA THE DEVICE AND RECHECKED VIA THE ANALYZER THE R-WAVES WERE LOW. REPOSITIONING THE LEAD DID NOT RESULT IN FIXATION. TISSUE IMPINGEMENT WAS SUSPECTED. ANOTHER LEAD WAS PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS MRI IMPLANTABLE PACING LEAD NVN MEDTRONIC PUERTO RICO, INC. 5086MRI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other