BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI SURESCAN

    MDR report key: 11176649 · Received January 15, 2021

    Report

    Report Number
    2649622-2021-00981
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 29, 2020
    Report Date
    January 15, 2021
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169708198
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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 DURING IMPLANT THAT THE PACING LEAD EXHIBITED UNDERSENSING DETECTION ERROR AND INSULATION DAMAGE. THE LEAD WAS REPLA CED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74057 CAPSUREFIX NOVUS MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652 00643169708198

    Patients

    Seq Age Sex Outcome Treatment
    1