MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-30

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Material Protrusion/Extrusion (2979)

Patient Problems Pain (1994); Weight Changes (2607)

Event Date 04/01/2015

Event Type  Injury  

Event Description

It was reported that the patient has been feeling 'shocks' in the neck at the electrode area for the last few months.X-rays were taken with no issues noted with the vns device.The vns device was tested by the physician with no issues noted.It was also reported that the patient had surgery on his esophagus on (b)(6) 2015, which has caused a 70 lbs.Weight loss and is causing the generator and lead to protrude.The 'shocks' started sometime after this procedure.It was reported that the pain doesn't happen all the time, but is often, and not with every stimulation.It was reported that the patient had the vns device diagnostics run while the patient was turning his head in multiple directions and there was no change in the impedance value.It was also reported that the 'shocks' stopped when the device was programmed off and the pain only occurs during stimulation.The output current was reduced and the off time was increased on (b)(6) 2015 to try to resolve the pain.The patient stated that the pain decreased but that the pain was still present.The patient was referred for generator replacement.No known surgical interventions have been performed to date.

Event Description

It was reported that the patient underwent a full revision surgery on (b)(6) 2015 due to reported pain and shocking sensations.It was reported the surgery was performed for patient comfort.It was also reported that the patient's new vns system was programmed on after surgery and the shocking sensation appeared to have resolved.Neither the lead nor the generator have been received to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• 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: 4922369
• MDR Text Key: 6056593
• Report Number: 1644487-2015-05200
• 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,company representati
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2015
• Device Model Number: 304-30
• Device Lot Number: 201868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2011
• 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): Other
• Patient Age: 17 YR