BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 6172761 · Received December 13, 2016

    Report

    Report Number
    1644487-2016-02852
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 18, 2016
    Report Date
    June 7, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, CYBERONICS, OR CYBERONICS' EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS¿ OR "MALFUNCTIONS¿. THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND CYBERONICS OBJECTS TO THEIR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW LEAD IMPEDANCE WAS REGISTERED ON A VNS PATIENT'S GENERATOR. THE BATTERY LIFE OF THE GENERATOR WAS REPORTED TO BE NORMAL. ATTEMPTS FOR ADDITIONAL PERTINENT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    X-RAY IMAGES WERE PERFORMED BY THE PATIENT¿S SURGEON. HE ASSESSED THAT THE PATIENT¿S VNS SYSTEM APPEARED INTACT IN THE AVAILABLE IMAGES. SURGERY TO REMOVE THE PATIENT¿S LEAD HAS NOT OCCURRED TO DATE. NO ADDITIONAL PERTINENT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S VNS WAS EXPLANTED. THE SITE REPORTEDLY DISCARDED THE EXPLANTED GENERATOR AND LEAD. NO ADDITIONAL PERTINENT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE OFFICE OF THE TREATING PHYSICIAN SHOWED THAT SHE WAS NOT ABLE TO IDENTIFY THE PATIENT. NO ADDITIONAL PERTINENT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    INFORMATION LEADING TO THE IDENTIFICATION OF THE SUSPECT DEVICE WAS RECEIVED BY THE MANUFACTURER. THE DEVICE HISTORY RECORDS OF THE IMPLANTED GENERATOR AND LEAD WERE REVIEWED BY THE MANUFACTURER. IT WAS FOUND THAT ALL SPECIFICATIONS WERE MET PRIOR TO DISTRIBUTION. NO ADDITIONAL PERTINENT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822235 LEAD MODEL UNKNOWN LEAD LYJ CYBERONICS, INC. 304-20 202275

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR