BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 2980454 · Received February 27, 2013

    Report

    Report Number
    1644487-2013-00530
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 6, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT¿S GUARDIANS REPORTED THAT THE PATIENT¿S DEVICE REMAINED DISABLED. THE PATIENT¿S MOTHER STATED THAT, PER THE ENT, THE ¿NERVE APPEARS TO BE WORKING.¿ THE PATIENT EATS AND DRINKS NORMALLY BUT CANNOT SWALLOW WATER IF HIS HEAD IS TILTED BACK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT¿S GRANDMOTHER THAT THE PATIENT SAW AN ENT SEVERAL WEEKS AGO AND THAT WAS TOLD THAT BOTH OF THE PATIENT¿S VOCAL CORDS ARE WORKING NORMALLY NOW. THE PHYSICIAN STATED THAT THE RIGHT AND THE LEFT ARE MOVING SYMMETRICALLY AT THIS TIME AND IT IS OKAY TO TURN THE VNS DEVICE ON.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT'S GUARDIAN REPORTED TO THE NEUROLOGIST'S OFFICE SEVERAL DAYS AFTER SURGERY TO REPORT THAT THE PATIENT WAS EXPERIENCING VOCAL CORD TROUBLE AND DIFFICULTY SWALLOWING. AT THE RECOMMENDATION OF AN ENT (WHO WAS NOT THE IMPLANTING PHYSICIAN), THE NEUROLOGIST DELAYED THE DATE FOR THE VNS TO BE TURNED ON UNTIL LATE FEBRUARY IN HOPES ISSUE WILL BE RESOLVED FOR THE PATIENT BY THEN. THE PATIENT HAD VNS IMPLANTED ON (B)(6) 2013. FOLLOW-UP WITH THE SURGICAL COORDINATOR ON (B)(6) 2013 REVEALED THAT THE PATIENT WAS DOING MUCH BETTER SINCE IMPLANT. THE SYMPTOMS BEGAN IMMEDIATELY AFTER SURGERY ON (B)(6) 2013 IN WHICH THE PATIENT HAD SEVERE DYSPHAGIA WHERE HE WAS UNABLE TO SWALLOW THIN LIQUIDS. THE DEVICE WAS STILL NOT TURNED ON AT THIS TIME, SO IT WAS BELIEVED TO BE DIRECTLY RELATED TO SURGERY. THE COORDINATOR INDICATED THAT THE VAGAL NERVE MAY HAVE BEEN BRUISED, BUT SHE IS NOT SURE. THE PATIENT WAS DISCHARGED AFTER IMPLANT BUT WAS RE-HOSPITALIZED VIA THE ER DUE TO HIS SYMPTOMS. HE WAS EVALUATED BY AN ENT AND A SCOPE WAS PERFORMED. PER THE REPORT, THE RIGHT VOCAL CORD APPEARED NORMAL, BUT THE LEFT VOCAL CORD WAS PARALYZED IN AN INTERMEDIATE POSITION. HE DID HAVE GOOD ACCOMMODATION OF THE CORDS. A SPEECH THERAPIST CAME INTO EVALUATE HIM BUT NO INTERVENTIONS WERE NOTED TO HAVE BEEN TAKEN. HE IS NOT GOING TO SPEECH THERAPY FOR SWALLOWING. THE GRANDMOTHER LATER REPORTED TO THE SURGEON'S OFFICE THAT THE PATIENT IS ABLE TO DRINK THIN LIQUIDS THROUGH A STRAW SLOWLY AND CANNOT DRINK WITH A CUP OR WATER BOTTLE. THEREFORE, IT WAS REPORTED THAT HE IS STILL HAVING ISSUES ALSO INCLUDING COUGHING. THE PATIENT WAS SCHEDULED TO SEE AN ENT AND FOR FURTHER FOLLOW-UP WITH THE SURGEON. HOWEVER, ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    FOLLOW-UP WITH THE SURGICAL COORDINATOR ON (B)(6) 2013 REVEALED THAT THE PATIENT SAW AN ENT SPECIALIST, WHO SAW CONTINUED PARALYSIS OF THE ONE CORD (LEFT) BUT DID SEE A LITTLE IMPROVEMENT. THE PATIENT IS REPORTEDLY STILL HAVING SOME ISSUES WITH EATING AND THIN LIQUIDS. AT THIS TIME, THEY ARE HOLDING TIGHT ON CHANGING ANYTHING. THE TREATING NEUROLOGIST STILL HAS NOT TURNED ON VNS, ALTHOUGH THE SURGEON IS COMFORTABLE WITH HIM TURNING IT ON. THE NEUROLOGIST WANTS TO HOLD OFF FOR ANOTHER 3-4 MONTHS TO ALLOW THE PATIENT'S CORD TO HEAL. INTERESTINGLY, THE PATIENT HAS NOT HAD ANY SEIZURES. SHE REPORTED THAT THEY ARE STILL HOPEFUL HE WILL HAVE IMPROVEMENT OF THE NERVE PARALYSIS. THE PATIENT DID SEE A SPEECH THERAPIST (FEEDING THERAPIST) BUT THE THERAPIST/PHYSICIAN DID NOT FEEL THAT IT WOULD DO A LOT OF GOOD AT THIS POINT AS HE IS CONTINUING TO HEAL, SO HE IS NOT CONTINUING THE SPEECH THERAPY AT THIS POINT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT¿S CAREGIVER REPORTED THAT, IMMEDIATELY POST-OPERATIVELY, THE PATIENT HAD TROUBLE WAKING UP FROM ANESTHESIA. HE WAS PUT INTO THE PEDIATRIC ICU AND WAS THERE FOR 30 HOURS WHILE ATTEMPTS WERE MADE TO WAKE HIM. CT SCANS WERE TAKEN BUT THE CAUSE OF THE ISSUE WAS NOT CONFIRMED. THE PATIENT WAS STILL UNABLE TO SWALLOW WATER WHEN HIS HEAD WAS TILTED BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83442 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 202205

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention