MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problems Chest Pain (1776); Nausea (1970); Tingling (2171); Discomfort (2330); Difficulty Chewing (2670)

Event Date 02/24/2016

Event Type  Injury  

Event Description

The patient was seen at the hospital with a need for a mri scan on (b)(6) 2016.At that time the patient was directed to their physician in order to proceed with device disablement prior to the mri.But it is unknown if the device was disabled prior to mri or if the mri was performed.On (b)(6) 2016, the patient was at the hospital due to experiencing chest pain.The patient also experienced discomfort in both neck and chest during stimulation, tingling sensations, voice alteration, nausea and issues with chewing.A nurse at the treating hospital requested that a company representative visit to turn the device off.A therapeutic consultant, who was present at the hospital at that time, disabled the device (both normal and magnet mode).Diagnostics were performed and reported to be within normal limits.It was unclear if the patient experienced a hear attack.Patient was asked to follow up with the neurologist once discharged.Additional relevant information has not been received.

Event Description

Additional information was received that a physician at the hospital believed that the vns could have been contributing in someway to patient's cardiac problems.However, the patient has had a cardiac pacemaker for a long time and the neurologist does not feel that the vns has contributed in anyway to patient's heart problems.Per the neurologist, the vns has helped his seizures dramatically and is concerned with the idea of patient's generator being turned off.It is unknown if the vns was disabled prior to the mri.The diagnostic tests have always been within normal range in the past.The patient has a long history of cardiac problems.The patient is currently seen another neurologist.No other relevant information was received.

• Brand Name: PULSE GEN MODEL 105
• 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: 5508303
• MDR Text Key: 40630270
• Report Number: 1644487-2016-00579
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/24/2016

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: 05/31/2015
• Device Model Number: 105
• Device Lot Number: 202575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/24/2016
• Initial Date FDA Received: 03/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2013
• 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: 53 YR