BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3860166 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05559
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    January 1, 2009
    Report Date
    March 27, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 MEDICAL PRODUCTS: ADDRL1, IPG, IMPLANTED: (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CORONARY ARTERY BYPASS GRAFT SURGERY IN 2009, THE RIGHT ATRIAL (RA) LEAD WAS COMPROMISED FROM THE RA CANNULA. THE RA LEAD THRESHOLDS HAD BEEN HIGH SINCE THE SURGERY. THE LEAD WAS 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
    337897 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R 5076 LEAD