BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2811950 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16646
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 23, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE LEAD WAS ABLE TO SENSE AND PACE IN UNIPOLAR BUT WAS NOT ABLE TO SENSE OR PACE IN BIPOLAR. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED INSTEAD. IT WAS ALSO NOTED THAT THE PHYSICIAN GAVE AN UPDATE THE NEXT DAY THAT AFTER REMOVAL OF THE LEAD HE NOTICED THAT THE HELIX WAS NOT ABLE TO COME OUT AND BELIEVES IT NEVER CAME OUT IN SPITE OF SEVERAL ATTEMPTS TO SCREW-IN THE HELIX DURING THE IMPLANT ATTEMPT. 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