BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 8863340 · Received August 6, 2019

    Report

    Report Number
    2649622-2019-13720
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    July 11, 2019
    Report Date
    August 6, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169633759
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    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 ONE MONTH POST IMPLANT PROCEDURE THE PATIENT EXPERIENCED WEAKNESS. A REMOTE TRANSMISSION INDICATED ATRIAL LEAD UNDERSENSING DURING ATRIAL TACHYCARDIA / ATRIAL FIBRILLATION EPISODES. THE ATRIAL LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658964 CAPSUREFIX NOVUS LEAD MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52 00643169633759

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR W1DR01 IPG, 5076-58 LEAD