BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2790435 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15333
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 20, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE LEAD SEGMENTS WAS RETURNED TO THE MANUFACTURER AND ANALYZED AND NO ANOMALIES WERE FOUND. THE LEAD ELECTRODE DISTAL END WAS COVERED IN BLOOD. THE LEAD WAS STRETCHED AND HAD APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING DISCOMFORT FOLLOWING IMPLANT OF THE DEVICE AND LEADS. IT WAS ALSO REPORTED THAT THE REPORT OF DISCOMFORT BY THE PATIENT WAS UNABLE TO BE REPLICATED WITH MODIFICATION TO PACING OUTPUTS. THEREFORE THE DEVICE AND ATRIAL AND VENTRICULAR LEADS WERE REMOVED AND NOT REPLACED. 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 31 YR Hospitalization| R