BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2790366 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15324
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 17, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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: (B)(4) - THE FULL LEAD WAS RETURNED, ANALYZED AND THE LEAD WAS STRETCHED. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, THE PROXIMAL CONDUCTOR WAS STRETCHED, THE INNER INSULATION WAS KINKED/BUCKLED, THE INNER TUBING WAS KINKED/BUCKLED, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD APPEARED TO HAVE BEEN DAMAGED AT IMPLANT. IT WAS VISUALLY NOTED THAT THE LEAD WAS RETURNED WITH THE HELIX FULLY EXTENDED AND THE LEAD HAD BEEN STRETCHED CAUSING THE INNER INSULATION TUBING TO BUCKLE WHICH PREVENTS THE HELIX FROM FUNCTIONING PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE HELIX MECHANISM OF THE LEAD WAS DEPLOYED, BUT THE HELIX WAS UNABLE TO RETRACT. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED DURING THE PROCEDURE. 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