BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2812087 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16655
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 2, 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
    NY, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DAY AFTER THE IMPLANT THE RIGHT ATRIAL (RA) LEAD WAS FOUND TO BE DISLODGED. IT WAS ALSO REPORTED THAT DURING THE INITIAL IMPLANT THE HELIX TOOK GREATER THAN 40 TURNS TO EXTEND AND IT IS BELIEVED THAT THE HELIX MAY HAVE NOT BEEN FULLY EXTENDED AT IMPLANT. THE RA LEAD WAS REPOSITIONED AND 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 66 YR Required Intervention 5086MRI IMPLANTABLE PACING LEAD| ADDR01 IMPLANTABLE PULSE GENERATOR