BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2953233 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01000
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 26, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. PRODUCT: 6947 IMPLANTABLE TACHY LEAD (B)(6) 2009; D224TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD WAS NOT CAPTURING AT MAXIMUM OUTPUT, AND THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR EARLIER THAN EXPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. THE LEAD REMAINS IMPLANTED, BUT THE DEVICE WAS PROGRAMMED TO VVIR DUE TO PATIENT BEING IN CHRONIC ATRIAL FIBRILLATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55763 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 559453

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Hospitalization| R 4194 IMPLANTABLE PACING LEAD