BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1230026 · Received November 12, 2008

    Report

    Report Number
    1644487-2008-02730
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 14, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S VNS DEVICE WAS EXPLANTED DUE TO INTOLERABLE SIDE EFFECTS. THE PATIENT FELT LIKE HER THROAT WAS CLOSING AND IT WAS HARD TO BREATHE. HOWEVER, THE PHYSICIAN INDICATED THAT THE MAIN CONCERN FOR REMOVING VNS WAS THE PATIENT'S FUTURE NEED FOR AN MRI. AFTER VNS WAS EXPLANTED, THE PHYSICIAN INDICATED THE PATIENT'S TROUBLE SWALLOWING HAS CONTINUED. THE PATIENT WAS DIAGNOSED WITH LEFT VOCAL CORD PARALYSIS. THE PHYSICIAN ALSO STATED THAT THE PARALYSIS MAY BE ASSOCIATED WITH SOME OF HER DIFFICULTY SWALLOWING. THE EXPLANTED PRODUCT WAS RETURNED TO THE MANUFACTURER. PRODUCT ANALYSIS REVEALED NO ANOMALIES WITH THE GENERATOR OR LEAD. BOTH PERFORMED ACCORDING TO SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 MUZ CYBERONICS, INC. 302-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other