MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Apnea (1720); Dysphagia/ Odynophagia (1815); Dyspnea (1816)

Event Date 07/14/2016

Event Type  Injury  

Event Description

It was reported the patent had experienced obstructive sleep apnea related to vns.The physician explained that the vns settings were decreased and the obstructive sleep apnea resolved.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Clinic notes from three of the patient's office visits were later received.The clinic notes showed that the vns was working as intended as diagnostics results were ok.The notes also showed the patient was having trouble breathing when the device stimulates and the vns settings were adjusted for tolerability.The next set of notes speaks to the patient¿s severe headaches, poor sleep, and dyspnea on exertion, all worsening since the vns implant.The patient was unable to catch her breath after just a brief walk from the waiting room to the exam room, and her breathing had a very airy quality during the entire stimulation period.A fluoroscopic evaluation of the diaphragm movement was arranged and observed.No asymmetry of diaphragmatic movement was noted despite obvious dyspnea during the study.A bedside swallow test of water both between and during stimulation showed increase effort during stimulation, but no choking or aspiration.The integrity of the phrenic nerve function was confirmed, but dyspnea and dysphagia continued; therefore the vns frequency was turned down and the symptoms mostly resolved.The following notes showed the patient¿s seizures were half as frequent now.It was also explained that the patient has had headaches for years, which started after her aneurysm, and continue to get worse as she gets older.

• Brand Name: PULSE GEN MODEL 106
• 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: 6439990
• MDR Text Key: 71060940
• Report Number: 1644487-2017-03502
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/29/2017
• Device Model Number: 106
• Device Lot Number: 203831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 56 YR