MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Arrhythmia (1721); Chest Pain (1776)

Event Date 09/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that this patient was in the er complaining of continual shocking in her neck from the vns, the patient's device¿s output current was lowered, and diagnostics tests were performed and were within normal limits.The patient was noted to be seizure and medication free where she was previously on 9 medications.The patient had a fall recently, and the pain was said to originate in the generator site and radiates into the neck, jaw and face area.The pain felt continuous in the chest and neck areas.During the appointment with the nurse, it was observed that the patient had an irregular/fast heart rate that was concerning to the nurse.The patient¿s device was disabled and the pain subsided along with the heart rate issues.The patient was said to still be sore despite no stimulation.An ekg was taken, and was said to be normal, and the patient may be referred for revision due to the issue.The nurse was concerned there was a device malfunction due to the recent events, but diagnostics were within normal limits.Additional information was received that the patient previously was having 10 seizures a day before vns, and was on 9 medications, and after vns she had been completely seizure free.The device was disabled by her nurse practitioner, and the patient had 4 seizures that following night.The patient therefore went back to the er where the doctor was skeptical if they were actual seizures or not, as the patient is in a perpetual state of hysteria.Due to the patient¿s reported seizures, the device was programmed back on.Additional information was received from the patient's provider.They mentioned that the patient feels stimulation all the time, but the device is only going off every 5 minutes, so the doctor is not sure what the patient is feeling.The magnet was used at night during one of the patient's seizures, and the patient woke up in pain.The provider doesn't know if the pain is real or what exactly is going on.The doctor thinks the patient could possibly be getting down to the end of her battery life, even though she recognized it was okay according to system diagnostics.The neurologist from their clinic believes the patient is having pseudo-seizures, because the patient is very anxious.The patient mentioned being very light headed and dizzy and almost passed out before seeing the nurse practitioner (np) at the clinic.The patient was said to have sinus arrhythmia prior to having the vns implanted.The nurse was able to hear some heart irregularities that she couldn't identify when the vns was on.When the vns was disabled, and they were monitoring the patient, it was noted that no cardiac issues came up; therefore the nurse believes that the vns may have exacerbated some of the patient's heart issues.The patient's heart rate rose to about 110bpm at one point, but the nurse believes this to be from the patient's anxiety and previous heart condition.The nurse mentioned she did not know where the pain is coming from, or why, because the device looks okay, according to diagnostics.The nurse also mentioned that she palpated the patient's chest and neck, and the patient did not have any pain or soreness.Diagnostics were run when the patient was in many different positions and all diagnostics were within normal limits.No surgical intervention has occurred to date.

Event Description

It was reported that surgery has occurred for this patient's generator replacement.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6942048
• MDR Text Key: 89240204
• Report Number: 1644487-2017-04576
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2012
• Device Model Number: 103
• Device Lot Number: 2918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 10/11/2017
• Supplement Dates Manufacturer Received: 02/02/2018
• Supplement Dates FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 21 YR