BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 4970664 · Received August 5, 2015

    Report

    Report Number
    2649622-2015-08411
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    May 18, 2015
    Report Date
    March 1, 2021
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS POSSIBLE OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD AS THERE WERE STORED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION THAT MAY NOT HAVE BEEN REAL. IT WAS NOTED THAT THE CAPTURE THRESHOLDS HAD INCREASED FROM THE TIME OF IMPLANT AND WERE ABOVE THE NORMAL RANGE. IT WAS ALSO NOTED THAT THE P-WAVES WERE SMALL. THE 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
    516746 CAPSUREFIX NOVUS LEAD MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00092 YR A2DR01 IPG, 5076-58 LEAD