BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2951978 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00336
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. CONCOMITANT PRODUCTS: (B)(4) IMPLANTABLE PACING LEAD - 2012 (B)(6); (B)(4) IMPLANTABLE HEART VALVE - 1986 (B)(6). (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 FOLLOWING THE IMPLANT, THE DEVICE WAS INTERROGATED AND THE ATRIAL LEAD WAS FOUND TO BE NOT SENSING OR CAPTURING. THE LEAD WAS DETERMINED TO BE DISLODGED, AND WAS REPOSITIONED. THE LEAD REMAINS IN USE. THE PATIENT IS ENROLLED IN THE SURESCAN PAS CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56858 CAPSUREFIX NOVUS MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI45

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER