BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3860286 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05509
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 11, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: A 6947-65 LEAD, IMPLANTED (B)(6) 2009. YRIRHXC1685 STENT GRAFT, IMPLANTED: (B)(6) 2006. YRECXC22375 X2, STENT GRAFTS IMPLANTED: 2006. YRBRHXC2816135 STENT GRAFT IMPLANTED: 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS NOT SENSING AND THE LEAD WAS PROGRAMMED OFF. IT WAS ALSO REPORTED BY THE PATIENT THAT A PREVIOUS RIGHT VENTRICULAR (RV) LEAD WAS BROKEN. THE RV LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343351 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention 7278 ICD