BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 11524048 · Received March 19, 2021

    Report

    Report Number
    2649622-2021-05271
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 22, 2021
    Report Date
    March 19, 2021
    Manufacturer
    MPRI
    Product Code
    NVN
    UDI-DI
    00763000130800
    PMA / PMN Number
    P030036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 THAT THE PACING LEAD WAS ATTEMPTED/USED DURING IMPLANT OF THE IPG SYSTEM. A NON MEDTRONIC PACING LEAD WAS SUCCESSFULLY PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427343 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