BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2952334 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00505
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 7, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089/S046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    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: 5054 IMPLANTABLE PACING LEAD (B)(6) 2005.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS BEING SEEN IN THE CLINIC FOR A LEAD WARNING. IT WAS NOTED THERE WAS ATRIAL OVERSENSING, RAISED CAPTURE THRESHOLDS AND VARYING IMPEDANCES ON THE ATRIAL LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS BEING SEEN IN THE CLINIC FOR A LEAD WARNING. IT WAS NOTED THERE WAS ATRIAL OVERSENSING, RAISED CAPTURE THRESHOLDS AND VARYING IMPEDANCES ON THE ATRIAL LEAD. THE LEAD WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57341 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 559453

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R E2DR01AA IMPLANTABLE PULSE GENERATOR