BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2965211 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01583
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 4, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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: 4193 IMPLANTABLE PACING LEAD (B)(6) 2009; D224TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE ROUTINE CHANGE OUT OF THE DEVICE, UNDERSENSING OF ATRIAL FIBRILLATION (AF) WAS NOTED ON ATRIAL ELECTROGRAM (EGM). MODE SWITCHED OCCURRED BUT UNNECESSARY ATRIAL PACING WAS DEMONSTRATED OWING TO UNDERSENSING. THE PATIENT'S HISTORY INDICATED PATIENT IN PERSISTENT AF, POST OPERATIVELY THE DEVICE WAS REPROGRAMMED TO PREVENT UNNECESSARY ATRIAL PACING AND CONSERVE BATTERY. THE ATRIAL 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
    67158 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention 6947 IMPLANTABLE TACHY LEAD