BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2791295 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14823
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 10, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THE LEAD WAS STRETCHED. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS DISTORTED, THE INNER INSULATION WAS KINKED/BUCKLED, THE INNER INSULATION WAS TORN, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD APPEARED DAMAGED AT IMPLANT. THE ANALYST COMMENTED THAT THE LAD HAS BEEN STRETCHED CAUSING THE INNER TUBING TO BUCKLE. THIS PREVENTS PROPER TORQUE TRANSFER WHEN TURNING THE IS-1 PIN. THE LEAD WAS RECEIVED WITH HELIX FULLY RETRACTED. WHEN THE HELIX WAS RETRACTED DURING THE PROCEDURE, THE IS-1 CONNECTOR PIN WAS TURNED AN EXCESSIVE NUMBER OF TIMES, RESULTING IN DISTORTION OF THE DISTAL CONDUCTOR WITHIN THE CONNECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING IMPLANT THAT DUE TO BAD ELECTRICAL VALUES THE LEAD WAS REPOSITIONED THREE TIMES. AFTER THE SECOND ATTEMPT, IT WAS NOT POSSIBLE TO MOVE THE HELIX OF THE LEAD OUT OR IN. THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. 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 Other