BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4160662 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11800
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 4, 2014
    Report Date
    July 9, 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
    HEALTH PROFESSIONAL

    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: A 5076-52 LEAD: (B)(6) 2008. A 5076-45 LEAD: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NORMAL DEVICE UPGRADE THE RIGHT VENTRICULAR (RV) LEAD WAS CUT DURING THE LASER EXTRACTION. THE RV LEAD WAS DISCARDED. A NEW RV LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641526 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R 8042B IPG