BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 2870353 · Received December 12, 2012

    Report

    Report Number
    1644487-2012-03305
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 19, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS SEIZURE FREE AND HIS VOICE IS BACK TO. AS NOTED AT HIS FOLLOW UP OFFICE VISIT THE WEEK OF (B)(6) 2013.

    Description of Event or Problem · 1

    A VNS PATIENT CALLED TO REPORT THAT SINCE THEIR IMPLANT (B)(6) 2012, THEY WERE HAVING ISSUES. IT WAS REPORTED THAT SINCE HE HAD HIS VNS PLACED, HE HAS HAD SHORTNESS OF BREATH AND VOICE ALTERATION THAT WON'T GO AWAY. THE PATIENT ALSO REPORTED THAT HE HAD ONE OF THE WORST SEIZURES LAST NIGHT THAT HE HAS EVER HAD. THE PATIENT'S VNS WAS NOT PROGRAMMED ON. THE PATIENT REPORTED THAT THEIR NEUROLOGY OFFICE WOULD NOT PROGRAM HIS VNS ON TILL HIS SHORTNESS OF BREATH AND VOICE ALTERATION RESOLVE. THE ESTIMATED TIME OF SURGERY WAS 45 MINUTES. THERE WERE NO COMPLICATIONS REPORTED DURING THE PROCEDURE. FINAL INTERROGATION SHOWED DEVICE WAS AT 0.0 OUTPUT CURRENT, AND 0.0 MAGNET CURRENT. THE PATIENT WAS SEEN BY AN ENT PHYSICIAN AND IT WAS NOTED THAT HIS LEFT VOCAL CORD WAS "WEAK" DUE TO VOCAL CORD PARALYSIS. THE PATIENT REPORTED THAT THE ENT AND IMPLANTING SURGEON SAID HIS DEVICE COULD BE TURNED. THE PATIENT ALSO NO LONGER REPORTS SHORTNESS OF BREATH, BUT STILL HAS HOARSENESS. THE PATIENT IS SCHEDULED TO HAVE A PROCEDURE WITH THE ENT TO ADJUST HIS VOCAL CORDS CLOSER TOGETHER USING A SCOPE. FURTHER FOLLOWUP WILL BE PERFORMED TO ATTAIN MORE DETAILS ABOUT THE REPORTED EVENTS.

    Description of Event or Problem · 1

    GOOD FAITH ATTEMPTS WERE MADE AND NO FURTHER INFORMATION WAS ATTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 304 LEAD MODEL 304 LYJ CYBERONICS, INC. 304-20 3359

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention