BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 13504095 · Received February 10, 2022

    Report

    Report Number
    2649622-2022-02847
    Event Type
    Malfunction
    Date Received
    February 10, 2022
    Date of Event
    October 15, 2020
    Report Date
    February 10, 2022
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00681490124799
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCTS: 3093-28 MGU LEAD IMPLANTED (B)(6) 2013; 3058 MGU IPG IMPLANTED (B)(6) 2013. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCTS: 3093-28 MGU LEAD IMPLANTED (B)(6) 2013; 3058 MGU IPG IMPLANTED (B)(6) 2013. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND THE RIGHT VENTRICULAR (RV) LEAD COULD NOT CONFIRM CAPTURE. BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND THE RIGHT VENTRICULAR (RV) LEAD COULD NOT CONFIRM CAPTURE. BOTH LEADS REMAIN 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
    258901 CAPSUREFIX NOVUS LEAD MRI SURESCAN PERMANENT PACEMAKER ELECTRODE DTB MPRI 5076-45 00681490124799

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female 407652 LEAD, ADDR01 IPG