BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2964496 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01977
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. CONCOMITANT PRODUCT: 5086MRI IMPLANTABLE PACING LEAD - (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A WEEK OF IMPLANT, THE PATIENT COMPLAINED OF FEELING LETHARGIC. THE ATRIAL LEAD EXHIBITED CAPTURING ISSUES, AND AN X-RAY WAS PLANNED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A WEEK OF IMPLANT, THE PATIENT COMPLAINED OF FEELING LETHARGIC. THE ATRIAL LEAD EXHIBITED CAPTURING ISSUES, AND AN X-RAY WAS PLANNED. IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD WAS FOUND TO HAVE DISLODGED. THE 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
    67924 CAPSUREFIX NOVUS MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R RVDR01 IMPLANTABLE PACEMAKER