BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2812035 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17404
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    March 28, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THIS MODEL NUMBER, (B)(4) IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT, A PARTICIPANT IN THE SURESCAN POST-APPROVAL STUDY, DEVELOPED AN INFECTION AS THERE WAS REDNESS OF THE SKIN AND A PUSTULE ON THE SKIN "ON" THE DEVICE POCKET. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS. ALSO REPORTED WAS A DECREASE IN ATRIAL SENSING. THE P-WAVES WERE INITIALLY 3.9 MILLIVOLTS (MV) IN AMPLITUDE, LAST MEASUREMENT WAS 0.75 MV; NO ACTION WAS TAKEN REGARDING ATRIAL SENSING. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS WERE 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 76 YR Required Intervention