BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2131641 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10531
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 21, 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
    CO, 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 FOR (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. THE PROXIMAL CONDUCTOR WAS DISTORTED AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM. THE LEAD WAS RETURNED WITH THE HELIX FULLY EXTENDED AND THERE WAS BLOOD AND TISSUE ON IT. THE LEAD WAS STRETCHED AND DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING IMPLANT, THE ATRIAL LEAD REQUIRED OVER TEN PLACEMENTS WITH MULTIPLE DISLODGEMENTS. A POSSIBLE HELIX DEPLOYMENT MECHANISM FAILURE WAS SUSPECTED. THE LEAD WAS NOT USED AND A NEW 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
    1 CAPSUREFIX NOVUS MRI IMPLANTABLE PACING LEAD NVN MEDTRONIC PUERTO RICO, INC. 5086MRI ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other