BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURE XT DR MRI SURESCAN

    MDR report key: 8905650 · Received August 19, 2019

    Report

    Report Number
    3004209178-2019-15841
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    February 28, 2019
    Report Date
    August 19, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    UDI-DI
    00643169634589
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 BY THE PATIENT THAT SIX WEEKS AFTER THE PACING SYSTEM IMPLANT ONE LOW-VOLTAGE LEAD "WASN'T CONNECTED" TO THE IMPLANTABLE PULSE GENERATOR (IPG). THE LEAD AND IPG REMAIN 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
    700119 AZURE XT DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. W1DR01 00643169634589

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 5076-45 LEAD,5076-52 LEAD