BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 6078674 · Received November 4, 2016

    Report

    Report Number
    1644487-2016-02549
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    April 18, 2016
    Report Date
    July 3, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    REVIEW OF THE MANUFACTURER'S DATABASE REVEALED THAT HIGH IMPEDANCE WAS DETECTED ON SYSTEM DIAGNOSTICS ON (B)(6) 2016. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HAD INCREASED AGITATION AND INCREASED SEIZURES, WHICH WAS ASSOCIATED WITH LOSS OF THERAPY. THE PATIENT UNDERWENT REPLACEMENT OF GENERATOR AND LEAD DUE TO HIGH IMPEDANCE. THE SUSPECT PRODUCT HAS NOT BEEN RECEIVED TO DATE. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730974 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1095

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR