BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 3372834 · Received September 27, 2013

    Report

    Report Number
    1644487-2013-02953
    Event Type
    Injury
    Date Received
    September 27, 2013
    Date of Event
    June 13, 2008
    Report Date
    August 28, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE VNS DEVICE WAS REPLACED ON (B)(6) 2013. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THIS PATIENT REPORTED THAT THE LEAD HAS BEEN CLOSE TO THE VOCAL CORD SINCE IMPLANT. THERE WAS NO PAIN. THE PATIENT EXPERIENCED VOICE ALTERATION WITH MAGNET ACTIVATION. THE PATIENT WAS REFERRED FOR REVISION. THE PATIENT INDICATED THAT THE DEVICE SETTINGS COULD NOT BE INCREASED BECAUSE IT CAUSES HER TO HAVE DIFFICULTIES BREATHING. WHEN THE MAGNET IS USED, SHE HAS PROBLEMS CATCHING HER BREATH FOR AWHILE. SHE ALSO CANNOT MAKE BUT A "RASPY SQUEAK" FOR A SHORT WHILE AFTER MAGNET USE. AT THE CURRENT DEVICE SETTINGS, THE PATIENT DID NOT EXPERIENCE DIFFICULTY BREATHING. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489213 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200635

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other