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 Erythema (1840); Unspecified Infection (1930); Injury (2348); Reaction (2414)

Event Date 10/27/2014

Event Type  Injury  

Event Description

The surgeon reported that the patient¿s vagus nerve has been damaged after explant surgery.The patient was having difficulty swallowing after explant and was kept overnight as a result.The patient was put on a thickened diet with no regular liquids.Upon follow-up, the surgeon reported that the patient needed debridement and a skin flap for his wound.The patient had an allergic reaction to the device which contributed to the vagus nerve damage.It was reported on (b)(6) 2015 that the patient has had a good outcome from the thickened diet.

Manufacturer Narrative

Describe event or problem, corrected data: the initial report inadvertently did not include the vagus nerve damage.Upon further follow-up, the physician indicated that it was believed the event was related to the events reported on the initial report.

Event Description

It was reported that approximately two weeks after implant surgery ((b)(6) 2014), the neurologist turned on the patient¿s device to 0.25ma.During this time, the incision site became reddened.The patient¿s caregiver applied 40% zinc oxide which decreased the redness.When he saw the surgeon for follow up, the surgeon indicated that the incision had healed well.With continued increase in settings at following dosing appointment(s), it was reported that the area of the generator has become red and inflamed again in spite of the 40% zinc oxide.The neurologist advised that the patient see the surgeon.The caregiver felt like the patient¿s body may have been rejecting the device.She thought that she could see the metal of the generator through the skin.It was felt that the patient may have been picking at his device and that the mother reportedly removed the dressing earlier than advised.Hygiene may have also have been a contributing factor.The surgeon reported that the patient¿s skin over the generator has ¿basically sloughed off.¿ the patient was scheduled for explant surgery due to infection.Device diagnostics were reportedly within normal limits.Explant of the generator and portion of the lead occurred on (b)(6) 2015.At that time, the surgeon stated he felt that the issue was an allergic reaction more so than an infection.The patient saw plastic surgery on (b)(6) 2015 for the wound, they feel that they can suture rather than skin graft the chest.

Manufacturer Narrative

Manufacturer device history records were reviewed.Review of the manufacturer device history records confirmed sterilization was performed for both the generator and lead prior to distribution.

• Brand Name: PULSE GEN MODEL 105
• 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: 4444478
• MDR Text Key: 5401383
• Report Number: 1644487-2015-03688
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 12/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2016
• Device Model Number: 105
• Device Lot Number: 4008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2014
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 51 YR