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

Model Number 106

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Chest Pain (1776); Erythema (1840); Unspecified Infection (1930); Rash (2033); Burning Sensation (2146)

Event Date 12/16/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient was experiencing a sharp pain in the chest that was not related to stimulation.The patient had a recent generator replacement surgery, and the surgeon believed that the patient had an infection on (b)(6) 2016.The surgeon disabled the normal mode stimulation, but the pain continued.The surgeon then disabled the magnet mode and autostimulation mode on (b)(6) 2016.The patient's mother reported a red spot or rash on the patient's chest.She stated that the last time the patient's settings were changed was in the middle of (b)(6) 2016.The patient was also prescribed an antibiotic regimen by the surgeon that was to be completed on (b)(6) 2016.The patient reported feeling burning in his left chest on (b)(6) 2016 and that the area was red and warm to the touch.Chest x-rays were performed, and the surgeon stated that the generator had "shifted a little." clarification was requested, and the notes stated that there was a foreign object next the generator.However, it was discovered that the patient's mother placed the magnet over the generator for the x-ray, which was the "foreign object" that the surgeon saw.The patient's neurologist did not believe that the redness in the chest was related to vns in any way, and he advised against turning off the patient's output currents because the patient had good seizure control with vns.The device history records of the generator and lead were reviewed, and the devices were both sterilized prior to release.Due to the conflicting information, it is not known at this time if the patient has an infection or not.No additional relevant information has been received to date.

Event Description

It was clarified that the surgeon prescribed the antibiotics prophylactically.There was no evidence other than the redness and pain at the generator site to indicate that the patient had an infection.Also, the surgeon continued to believe that there was an infection because of the "foreign object" in the x-ray that turned out to be the magnet.The neurologist did not think the redness or pain was due to an infection, but most likely due to the patient picking at the site or from something that happened at school.It was also clarified that the generator had not shifted at all.No further intervention has occurred 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: 5529212
• MDR Text Key: 41260407
• Report Number: 1644487-2016-00648
• 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 Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/25/2017
• Device Model Number: 106
• Device Lot Number: 4541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2015
• 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: 14 YR