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 Pain (1994); Discomfort (2330)

Event Date 03/23/2015

Event Type  Injury  

Event Description

It was reported that the patient has had pain in the vns region of the neck since the first date of initial implant.Therefore, it was felt that since the patient was still complaining of pain with the replacement vns system, that the physician did not see any reason for it to remain implanted.It was felt to be removed more for patient comfort reasons.

Manufacturer Narrative

Describe event or problem: the initial report inadvertently did report this information.

Event Description

The patient had generator and lead replacement surgery on (b)(6) 2015 due to pain and painful stimulation.At that time, the physicians reported that the surgery was for patient comfort reasons and not to preclude a serious injury.The implant card reported that lead impedance was okay after replacement surgery.Additional information was later received that patient complained of pain after the surgery.Initially at post-op appointment on (b)(6) 2015, the notes recorded no post-operative complications and no patient complaints.The scars/incision sites were reported to be healed nicely.Later on (b)(6) 2015, the notes reported that the patient reported having continued problems with a burning sensation and a sensation of electricity around the vns site.The pain/discomfort did not improve after full replacement surgery.She could not tolerate this continued problem.The clinic notes from (b)(6) 2015 reported that the patient presented after full replacement complaining of pain in the area of the vagus nerve stimulator and neck.The patient reported that the pain was persistent if the device was not on.As a result, she wanted the device removed.The patient's device was programmed off due to the pain, and the physician assessed that it needs to be removed due to pain experienced even with the device off.The patient was referred for removal of the vns.The manufacturer¿s field clinical engineer attended the explant surgery on (b)(6) 2015.Explant of the generator and lead occurred on (b)(6) 2015, and the explanted devices were discarded.As a result, product analysis is unable to be performed.

Manufacturer Narrative

(b)(4).

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4760249
• MDR Text Key: 5948978
• Report Number: 1644487-2015-04653
• 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,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2016
• Device Model Number: 103
• Device Lot Number: 203154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2014
• 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: 50 YR