BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2638613 · Received July 3, 2012

    Report

    Report Number
    1644487-2012-01676
    Event Type
    Injury
    Date Received
    July 3, 2012
    Date of Event
    May 15, 2012
    Report Date
    June 7, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON (B)(6) 2012, A SURGEON'S OFFICE REPORTED THAT THEY HAD RECEIVED A PHONE CALL FROM A PATIENT'S MOTHER. THE MOTHER REPORTED THAT THE VNS PATIENT HAD BEEN EXPERIENCING CONTINUAL HOARSENESS, CHOKING, BLUE LIPS, FACE REDNESS, VOMITING, AND INFLAMMATION AT THE SURGICAL SITE. THE PATIENT'S MOTHER STATED THAT THE DEVICE WAS TURNED ON AT THE DATE OF SURGERY. AT FIRST, THE PATIENT'S COUGHING WAS MILD; HOWEVER, AS THE DAY PROGRESSED, THE COUGHING AND CHOKING BECAME WORSE. SHE REPORTED THAT THE PATIENT WAS FEELING ANXIETY AND, AS A RESULT, PACING DUE TO THE SIDE EFFECTS. SHE ALSO STATED THAT THE PATIENT FEELS "LIKE HER HEAD IS GOING TO EXPLODE." THE MOTHER ALSO REPORTED THAT THE PATIENT HAS NOT HAD A GRAND MAL SEIZURE IN TWO YEARS; HOWEVER, SHE HAS HAD TWO GRAND MAL SEIZURES SINCE IMPLANT AND WENT TO THE EMERGENCY ROOM. (THE DATE OF THE HOSPITAL VISIT IS UNKNOWN.) THE PATIENT WENT IN TO SEE HER NEUROLOGIST AND THE SETTINGS WERE DECREASED; HOWEVER, THE SYMPTOMS CONTINUED. THE PATIENT RETURNED TO THE NEUROLOGIST ON (B)(6) 2012 AND THE DEVICE WAS DISABLED; HOWEVER, THE MAGNET OUTPUT CURRENT WAS INTENTIONALLY NOT PROGRAMMED TO 0 MA, AND THE PATIENT AND MOTHER WERE TOLD TO SWIPE THE MAGNET IF THEY FELT A SEIZURE COMING ON. ON (B)(6) 2012, A PHYSICIAN'S OFFICE REPORTED THAT THEY HAD SPOKEN TO THE PATIENT'S MOTHER ON THIS DATE. THE MOTHER REPORTED THAT THE NECK INCISION WAS SWOLLEN (THERE WAS A SOMEWHAT HARD BUMP THERE THAT HURT WHEN TOUCHED). SHE ALSO STATED THAT EACH TIME THE DEVICE STIMULATED, THE PATIENT FELT LIKE SHE WAS BEING CHOKED, TURNED RED, THE LIPS TURNED BLUE, AND SHE WOULD VOMIT. WHEN THE PATIENT SPOKE, THE MOTHER NOTICED THAT THE NERVES WERE "PULLING AT HER UPPER LIP." ON (B)(6) 2012, A VOICEMAIL WAS RECEIVED FROM THE NEUROLOGIST. HE STATED THAT HE SAW THE PATIENT AND DISABLED THE OUTPUT CURRENT, EXPECT FOR MAGNET STIMULATION. THE PHYSICIAN STATED THAT THE PATIENT WAS PROBLEMATIC AND COULD NOT TELL IF THE PATIENT HAD A LOT OF ANXIETY OR IF THE EVENTS WERE ACTUALLY OCCURRING. HE STATED THAT THE PATIENT REPORTED CHOKING; HOWEVER, HE DID NOT SEE THIS AND THOUGHT HER SWALLOWING WAS NORMAL. HE ALSO STATED THAT THE PATIENT REPORTED TIGHTNESS IN HER THROAT AND COUGHING. IN ADDITION, HE STATED THAT THERE IS A LITTLE SWELLING AT THE NECK INCISION THAT WAS TYPICAL FOR SURGERY AND NOT ALARMING. ON (B)(6) 2012, THE NEUROLOGIST REPORTED THE PATIENT'S WOUNDS WERE FINE; HOWEVER THE PATIENT WAS VERY ANXIOUS ABOUT THE DEVICE AND WANTED IT REMOVED. THE NEUROLOGIST SUGGESTED USING VITAMIN E CREAM FOR THE WOUNDS AND GIVING THE HEALING PROCESS A CHANCE. THE NEUROLOGIST BELIEVED THAT THE DEVICE WAS STILL PROGRAMMED TO ONLY DELIVER MAGNET STIMULATION. THE NEUROLOGIST ALSO BELIEVED THAT IT WOULD BE BEST TO LEAVE THE DEVICE IN FOR A FEW MONTHS, ESPECIALLY AFTER WOUND HEALING. ON (B)(6) 2012, A SURGEON'S OFFICE REPORTED THAT THE PATIENT'S ANXIETY MADE THE MOTHER BECOME ANXIOUS AND ANY LITTLE PIN PRICK SENSATION CAUSED THEM TO CALL EVERYWHERE. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE TO DATE.

    Description of Event or Problem · 1

    ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. SURGERY IS STILL LIKELY, BUT HAS NOT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 3245

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R