BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3991592 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08026
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: 694765 LEAD, IMPLANTED: (B)(6) 2012; D314TRG ICD, IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEFT VENTRICULAR (LV) LEAD DISLODGED, EXHIBITED HIGH THRESHOLDS AND EVENTUAL LOSS OF CAPTURE. THE LEAD WAS REMOVED AND WILL BE REPLACED WITH A DIFFERENT LEAD. THE ATRIAL LEAD EXHIBITED POSITIONAL HIGH THRESHOLDS WITH OCCASIONAL NO CAPTURE, AND SMALL P-WAVE UNDERSENSING. THE ATRIAL LEAD WAS REPOSITIONED TO THE LATERAL WALL AND REMAINS IN USE. FURTHER, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO UNEXPECTED LONGEVITY - EARLY BATTERY DEPLETION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470823 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R 419488 LEAD