BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2953064 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00876
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 19, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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: IMPLANTABLE PACING LEAD (B)(4) 2011 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT A "TAPPING" SENSATION IN THEIR CHEST FROM THE RIGHT VENTRICULAR (RV) LEAD PACING. IT WAS INDICATED THAT THE SENSATION WAS REPRODUCIBLE WITH VENTRICULAR PACING AND THAT IT DID NOT BOTHER THE PATIENT MUCH. IT WAS NOTED THAT THE PATIENT ATRIA-VENTRICULAR (AV) CONDUCTION WAS CHANGING AND AFTER A RUN OF TRUE ATRIAL TACHYCARDIA THAT THE DEVICE WOULD MODE SWITCH AND VENTRICULAR PACE THE PATIENT AT THE PROGRAMMED AV DELAY. THE AV DELAYS HAD BEEN REPROGRAMMED LONGER TO DECREASE THE CHANCE OF VENTRICULAR PACING AND THE RV LEAD 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
    57860 CAPSUREFIX NOVUS MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR