BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2810791 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15795
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT DURING A DEVICE INTERROGATION THEY "COULDN'T GET A READING." IT WAS LATER REPORTED BY A COMPANY REPRESENTATIVE THAT THE ATRIAL LEAD THRESHOLD HAD INCREASED AND THE LEAD WAS NOT CAPTURING. ADDITIONALLY, THE PATIENT'S CLINIC NOTED THAT THE PATIENT DOES NOT WANT TO UNDERGO A LEAD REVISION. THE ATRIAL LEAD REMAINS IN USE. 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 57 YR Other RVDR01 IMPLANTABLE PULSE GENERATOR| 5086MRI IMPLANTABLE PACING LEAD