BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 10101501 · Received May 29, 2020

    Report

    Report Number
    2649622-2020-10233
    Event Type
    Injury
    Date Received
    May 29, 2020
    Date of Event
    April 28, 2020
    Report Date
    May 29, 2020
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00681490124867
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: W1DR01 IPG, IMPLANTED (B)(6) 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ON (B)(6) 2020: IT WAS FURTHER REPORTED THAT THE RA AND RIGHT VENTRICULAR (RV) LEADS EXHIBITED OVERSENSING AND CROSS TALK. THE RA AND RV LEADS WERE REPROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566088 CAPSUREFIX NOVUS LEAD MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58 00681490124867

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention