BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI SURESCAN

    MDR report key: 12187555 · Received July 19, 2021

    Report

    Report Number
    2649622-2021-14430
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Date of Event
    June 24, 2021
    Report Date
    July 19, 2021
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169708181
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: M7700-31 MECHANICAL VALVE, IMPLANTED: (B)(6)1980. 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 INTERMITTENT UNDERSENSING. THE RA 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
    1085240 CAPSUREFIX NOVUS MRI SURESCAN PERMANENT PACEMAKER ELECTRODE DTB MPRI 407645 00643169708181

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR W1DR01 IPG, 407652 LEAD.