BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 8825800 · Received July 25, 2019

    Report

    Report Number
    2649622-2019-13044
    Event Type
    Injury
    Date Received
    July 25, 2019
    Date of Event
    July 2, 2019
    Report Date
    July 25, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00681490124812
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    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 PATIENT WAS EXPERIENCING TRICUSPID VALVE REGURGITATION. THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED 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
    622286 CAPSUREFIX NOVUS LEAD MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52 00681490124812

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R 5076-45 LEAD, ADDR01 IPG