BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2790394 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14134
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    July 30, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    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 OF THE LEAD, THERE WAS BAD SENSING AND THRESHOLD VALUES. THE LEAD WAS THEN REPOSITIONED IN THE APEX. THE DAY AFTER IMPLANTATION, THE SENSING VALUE DECREASED. THE PHYSICIAN DECIDED TO SWITCH THE POLARITY TO UNIPOLAR WHICH RESULTED IN BETTER SENSING VALUES. THE PATIENT ALSO EXPERIENCED ANGINA PECTORIS AND WAS FOUND TO HAVE A PERICARDIAL EFFUSION, WHICH SUBSEQUENTLY RESOLVED. THE LEAD IS STILL IN USE. NO FURTHER 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 Life Threatening| R