BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 8666010 · Received June 4, 2019

    Report

    Report Number
    2649622-2019-09515
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 7, 2019
    Report Date
    June 4, 2019
    Manufacturer
    MPRI
    Product Code
    NVN
    UDI-DI
    00763000130800
    PMA / PMN Number
    P030036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 DURING THE IMPLANT PROCEDURE THE IMPLANTABLE PULSE GENERATOR (IPG) HAD A PACING PROBLEM AND NON-CAPTURE. THE DEVICE WAS REMOVED. THE RIGHT VENTRICULAR (RV) LEAD WAS CONNECTED TO THE ANALYZER AND THE THRESHOLDS INCREASED. THE LEAD WAS RE-POSITIONED AND RECONNECTED TO THE DEVICE WITH SATISFACTORY THRESHOLD MEASUREMENTS. THE PHYSICIAN OPTED TO REMOVE AND REPLACE THE IPG. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458798 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 74 YR 5076-52 LEAD