BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2082993 · Received May 4, 2011

    Report

    Report Number
    1644487-2011-00994
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 15, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A VNS PT THAT AFTER HER PROPHYLACTIC GENERATOR REPLACEMENT ON (B)(6) 2011, SHE STARTED EXPERIENCING DYSPHAGIA, DYSPNEA, VOICE ALTERATION AND DECREASE PERCEPTION OF STIMULATION. PT WAS INSTRUCTED BY SURGEON TO DISABLE THE DEVICE BY PLACING A MAGNET OVER THE GENERATOR. THE DYSPHAGIA AND VOICE ALTERATION BECAME LESS INTENSE BUT THEY WERE STILL PRESENT. PT REPORTED THAT SHE WAS HAVING DIFFICULTY BREATHING IMMEDIATELY AFTER SURGERY AS WELL. THE PT SAW A NEUROLOGIST AND HE REPORTED THAT ADVERSE EVENTS OF DYSPNEA, DYSPHAGIA AND VOICE ALTERATION WERE PRESENT EVEN AFTER THE DEVICE WAS DISABLED. HOWEVER, THE TREATING NEUROLOGIST DID NOT KNOW WHY THE PT HAD A DECREASED PERCEPTION OF STIMULATION EVEN THOUGH SHE WAS AT HER PREVIOUS SETTINGS. PT'S LAST KNOWN SETTINGS WERE 1.0MA/250USEC/30 SECONDS AND MAGNET MODE OF 1.25MA/500USEC/60 SECONDS. THE SYSTEM DIAGNOSTICS WERE WITHIN NORMAL LIMIT (OK/OK/OK/DCDC=1/ERI=NO). THE PT DECIDED TO LEAVE HER DEVICE 'ON' AND WAS ADVISED TO SEE AN ENT SPECIALIST. THE TREATING NEUROLOGIST BELIEVED THAT VOICE ALTERATION MAY BE RELATED TO INTUBATION AT THE TIME OF SURGERY. LATER, PT NOTIFIED THE MANUFACTURE THAT SHE WAS ADMITTED TO EMERGENCY ROOM AND THE ATTENDING PHYSICIAN AND NEUROSURGEON EXAMINED PT'S AIRWAYS AND BELIEVED THAT SHE HAS PARTIAL PARALYSIS OF THE VOCAL CORD. THE DEVICE WAS TURNED OFF AT THAT TIME. GOOD FAITH ATTEMPTS TO OBTAIN MORE INFO REGARDING PT'S VOCAL CORD PARALYSIS HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 A7531

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Hospitalization