BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2203024 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11604
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 17, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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): PARTIAL LEAD WAS RETURNED IN SEGMENTS AND PRIMARY ANALYSIS REVEALED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED. THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED) AND HELIX/LOBE MECHANISM. THE OUTER INSULATION WAS BREACHED CUT. THE LEAD APPEARED TO HAVE BEEN DAMAGED AT IMPLANT. VISUAL ANALYSIS REVEALED THAT THE LOCATION OF THE DISTORTED PROXIMAL CONDUCTOR AND CUT OUTER INSULATION CANNOT BE DETERMINED SINCE THE LEAD WAS RETURNED IN TWO PIECES AND THE LENGTH OF THE LEAD IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT WHEN THE DEVICE WAS BEING PLACED IN THE POCKET THE LEAD BROKE APPROXIMATELY FIVE INCHES FROM THE PIN ABOUT HALF AN INCH BEFORE THE SUTURE SLEEVE. THE LEAD WAS EXPLANTED 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
    1 CAPSUREFIX NOVUS MRI IMPLANTABLE PACING LEAD NVN MEDTRONIC PUERTO RICO, INC. 5086MRI ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other