BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 9177605 · Received October 10, 2019

    Report

    Report Number
    1644487-2019-01967
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    June 19, 2011
    Report Date
    October 10, 2019
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN INTERNAL PROGRAMMING HISTORY REVIEW HIGH IMPEDANCE WAS DISCOVERED ON THE PATIENT'S DEVICE DURING A SYSTEM DIAGNOSTICS TEST PERFORMED ON 06/19/2011. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970259 LEAD MODEL 302 LEAD MUZ CYBERONICS - HOUSTON 302-30 1565

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR