BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2812407 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16677
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 2, 2012
    Report Date
    January 16, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY (B)(4) PERFORMANCE DATA WAS RECEIVED AND ANALYZED. THE SAVE TO DISK PRIMARY FINDING NOTED SENSING FUNCTION OVERSENSING EMI/NOISE.

    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 THAT AFTER THE IMPLANT PROCEDURE, BOTH THE VENTRICULAR AND ATRIAL LEADS WERE NOTED WITH NOISE WHICH CAUSED OVERSENSING AND UNDER PACING. THE NOISE STOPPED WHEN THE POCKT WAS MANIPULATED, BUT RESUMED SHORTLY AFTER. THE LEADS WERE REPROGRAMMED TO ENSURE PACING IN THE PRESENCE OF THE NOISE. THE VENTRICULAR AND ATRIAL LEADS 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 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC PUERTO RICO, INC. 5086MRI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR