BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 4110421 · Received September 23, 2014

    Report

    Report Number
    1644487-2014-02428
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 26, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD BEING PLACED ON THE NERVE UPSIDE DOWN WAS CONFIRMED DURING LEAD REPLACEMENT SURGERY. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT REQUESTED THAT THE VNS BE EXPLANTED DUE TO EAR PAIN. THE PATIENT'S DEVICE WAS PROGRAMMED OFF, BUT THE PATIENT REQUESTED EXPLANT. IT WAS REPORTED THAT DESPITE THE LEAD REPLACEMENT. THE PATIENT CLAIMS TO STILL HAVE A BUZZING NOISE ALONG WITH SEVERE CONSTANT EAR PAIN. IT WAS REPORTED THAT DEVICE DIAGNOSTICS HAVE BEEN WITHIN NORMAL LIMITS AND THERE IS NO BELIEF OF DEVICE MALFUNCTION. THERE IS NO RELATIONSHIP OF THE VNS TO THE PATIENT'T BUZZING NOISE AND EAR PAIN. THE PATIENT UNDERWENT VNS EXPLANT ON 12/12/2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT¿S LEAD WAS IMPLANTED UPSIDE-DOWN ON THE PATIENT¿S NERVE. IT IS UNCLEAR HOW THE PHYSICIAN MADE THIS DETERMINATION. AN IMPLANT CARD WAS RECEIVED STATING THAT PATIENT UNDERWENT LEAD REPLACEMENT SURGERY ON (B)(6) 2014 DUE TO LEAD FAILURE. THE EXPLANTED LEAD HAS NOT BEEN RETURNED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT WAS REFERRED FOR SURGERY TO EXPLANT HER GENERATOR. THE PATIENT REPORTEDLY WAS HEARING A BUZZING NOISE FROM HER DEVICE. THE PATIENT¿S GENERATOR HAS NOT BEEN EXPLANTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592333 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 2727

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR