BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 8864790 · Received August 6, 2019

    Report

    Report Number
    2649622-2019-13752
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    June 27, 2019
    Report Date
    August 6, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169633742
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED DISLODGEMENT. THE LEAD WAS REVISED AND 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
    660552 CAPSUREFIX NOVUS LEAD MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45 00643169633742

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R 5076-52 LEAD, W1DR01 IPG