BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 10522445 · Received September 11, 2020

    Report

    Report Number
    1644487-2020-01195
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 19, 2020
    Report Date
    October 15, 2020
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MEDICAL PROFESSIONAL REPORTED THAT THEY TURNED OFF A PATIENT'S DEVICE FOR MRI BY INTERROGATING THE DEVICE, PERFORMING DIAGNOSTICS, RE-INTERROGATING, SETTING ALL OUTPUT CURRENTS TO ZERO AND APPLYING THE CHANGES. THEY PERFORMED DIAGNOSTICS AGAIN AND ALL OUTPUT CURRENTS WERE CONFIRMED TO BE AT 0 MA. AFTER THE MRI, THE DEVICE WAS INTERROGATED AND WAS FOUND TO BE AT THE ORIGINAL SETTINGS (NOT SET TO ZERO). DIAGNOSTICS WERE PERFORMED AGAIN TO CONFIRM THE SETTINGS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987628 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 204232

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR