BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3153502 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06053
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    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 6948 IMPLANTABLE TACHY LEAD (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S HAD OPEN HEART SURGERY. THE PHYSICIAN WAS CONCERNED THAT THE RIGHT ATRIAL (RA) LEAD MAY HAVE BEEN DISLODGED DURING THE SURGERY. TESTING REVEALED DIMINISHED SENSING AND NO CAPTURE OF THE RA LEAD. THE DEVICE WAS REPROGRAMMED FOR A FEW DAYS AND THE RA LEAD WAS LATER CAPPED AND REPLACED, NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256507 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5554

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R D314DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC