BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2791574 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14538
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    April 12, 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
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 TWO MONTHS POST IMPLANT THE PATIENT EXPERIENCED A PULMONARY EMBOLISM AND IT WAS UNKNOWN IF THE RIGHT VENTRICULAR (RV) LEAD WAS THE CAUSE. SINCE THE EMBOLISM, THE RV LEAD HAD POSSIBLY MOVED AND THE CAPTURE THRESHOLD HAD RISEN. THE OUTPUT ON THE LEAD WAS INCREASED AND IT REMAINS IN USE. NO FURTHER 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 84 YR Hospitalization| L| R RVDR01 IMPLANTABLE PULSE GENERATOR| 5086MRI IMPLANTABLE PACING LEAD