BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 10194728 · Received June 25, 2020

    Report

    Report Number
    1644487-2020-00842
    Event Type
    Malfunction
    Date Received
    June 25, 2020
    Date of Event
    June 2, 2020
    Report Date
    June 25, 2020
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750139
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED FOR GENERATOR REPLACEMENT. PRE-OP DIAGNOSTICS WERE NOTED TO BE OK. AFTER THE PATIENTS GENERATOR WAS REPLACED, OR DIAGNOSTICS NOTED HLI. THE PATIENTS LEAD WAS NOT REVISED DUE TO TIME CONSTRAINTS. THE PATIENTS GENERATOR WAS PROGRAMMED OFF. PATIENTS LEAD WAS LATER EXPLANTED. THE EXPLANTED LEAD HAS NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660140 LEAD MODEL 304 LEAD LYJ CYBERONICS - HOUSTON 304-20 5238 05425025750139

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR