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

Model Number 106

Device Problems Device Emits Odor (1425); Smoking (1585)

Patient Problems Burn(s) (1757); Chest Pain (1776); Burning Sensation (2146)

Event Date 08/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient stated she has been having a burning sensation under her skin where the vns generator was placed and had a burn mark.It was reported that the issue has been going on for a while (exact date not reported).The patient's mother also mentioned that she can sometimes smell a burning smoke smell coming from the patient's mouth when she talks.It was also reported that the patient feels the generator gets warm whenever it is interrogated.Additional information was received that the patient's device was disabled on (b)(6) 2016 due to persistent chest pain, and the patient was also referred to a surgeon for evaluation.The chest pain did reportedly resolve once the patient's device was disabled.No additional relevant information has been received to date.

Event Description

The patient consulted another physician, who believes that the patient's events are due to the placement of the device as opposed to the device itself.The patient complains of constant pain around the superior portion of the chest incision and at the neck incision where the electrode appears to course above the platysma muscle.The discomfort appears to be related to the fact that the implant was placed too superficially, such that it is in direct contact with the dermis and is irritating the skin.The patient states that these symptoms have been present since the device was placed.During stimulation, the patient was extremely uncomfortable and noted the following symptoms: sensation of tasting something burning, pulling sensation in her neck, burning sensation in the neck and near the generator, coughing and nausea.There was no discoloration or heating of the skin around the generator that the physician observed.Per the physician, the above symptoms would be most consistent with inadvertent placement of the device on the hypoglossal or glossopharyngeal nerve instead of the vagus nerve, or potentially placement too superiorly on the vagus, or current spread to those nerves,.Per the physician's opinion, these are not necessarily indicative of a malfunction in the device itself.In addition, the recorded impedance of the device was 2183 ohms confirms no lead related issues.Per the implant operative report, the lead was implanted on the vagus nerve near the jugular vein and carotid artery.No other relevant information was obtained from the operative report as to the cause of pain.Patient underwent full revision surgery on (b)(46 2016.The explanted products were not received to date.

• 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: 5405291
• MDR Text Key: 37333983
• Report Number: 1644487-2016-00216
• 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,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/02/2017
• Device Model Number: 106
• Device Lot Number: 4407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2015
• 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: 18 YR