BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZURE XT DR MRI SURESCAN

    MDR report key: 8665870 · Received June 4, 2019

    Report

    Report Number
    3004209178-2019-10786
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    May 7, 2019
    Report Date
    June 20, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    UDI-DI
    00643169634589
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEY HAD AN IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTED, "ONE OF THE WIRES HAS MOVED". THE PATIENT STATED THAT THE IPG WAS EXPLANTED AND REPLACED AS A RESULT. THE RIGHT ATRIAL (RA) 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
    459699 AZURE XT DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. W1DR01 00643169634589

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R 383069 LEAD, 5076-45 LEAD