BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4970796 · Received August 5, 2015

    Report

    Report Number
    2649622-2015-08344
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    May 5, 2015
    Report Date
    May 6, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 PRODUCTS: PRODUCT ID: A7700-22 MECHANICAL VALVE, IMPLANTED: (B)(6) 1996. PRODUCT ID: M7700-29 MECHANICAL VALVE, IMPLANTED: (B)(6) 1996. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD DISLODGED POST OPERATIVELY AND WAS REVISED AND PLACED BACK IN THE RIGHT ATRIUM. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513260 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Hospitalization| R 5076 LEAD, ADDR01 IPG