BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2122244 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07844
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    January 7, 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
    NL
    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. AT THE TIME OF THE INITIAL REPORT, THIS PRODUCT WAS NOT APPROVED IN THE U.S. EVALUATION SUMMARY (B)(4) THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND THE DISTAL CONDUCTOR CONNECTOR PIN BENT, BLOOD IN/ON HELIX/LOBE MECHANISM AND DAMAGE AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE IT WAS NOT POSSIBLE TO EXTEND THE HELIX MECHANISM. THE LEAD WAS ATTEMPTED, BUT NOT IMPLANTED AND A NEW LEAD WAS USED. 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 Other