BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 10132328 · Received June 9, 2020

    Report

    Report Number
    2649622-2020-10851
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Date of Event
    September 25, 2019
    Report Date
    June 9, 2020
    Manufacturer
    MPRI
    Product Code
    NVN
    UDI-DI
    00763000130800
    PMA / PMN Number
    P030036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    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 THE MEDTRONIC PACING LEAD WAS NOT CAPTURING. THE PACING 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
    599516 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 383069 00763000130800

    Patients

    Seq Age Sex Outcome Treatment
    1