BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2123615 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-08149
    Event Type
    Injury
    Date Received
    June 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MU
    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 NO ANOMALIES WERE FOUND. (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTED ATRIAL LEAD DISLODGED FROM THE MYOCARDIUM INFERIOR VENA CAVA, AS DID AN ATTEMPTED REPLACEMENT LEAD. IT WAS DECIDED TO REMOVE THE ATRIAL LEAD AND PLUG THE PORT. 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 Hospitalization| R