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

Model Number 304-20

Device Problem Disconnection (1171)

Patient Problems Pain (1994); Discomfort (2330); Neck Pain (2433)

Event Date 05/31/2012

Event Type  malfunction  

Event Description

It was reported that the patient feels pain at the generator site up to the neck area.It was reported that it is unclear whether or not the pain occurs with device stimulation.There has been no falls or trauma that may have caused the pain.Device diagnostics were within normal limits (3337 ohms).Clinic notes dated (b)(6) 2012 note that the patient has some vague complaints of neck pain over his left side, moving down to his left arm and leg.It was noted that the patient describes the pain at sharp in nature and that the patient attributes the pain to vns.Clinic notes dated (b)(6) 2015 note that the patient is having significant discomfort on his left side with vns stimulation.It was noted that the physician believes the generator and lead need to be replaced.The patient underwent generator and lead replacement.The implant card indicated that the generator and lead were replaced due to lead discontinuity and adverse event.No additional relevant information has been received to date.

Event Description

The explanted lead and generator were returned for evaluation.Analysis is underway but has not been completed to date.

Event Description

Analysis of the explanted generator was completed on 06/02/2015.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.Analysis of the explanted lead was completed on 06/04/2015.Other than the typical wear and explant related observations, no anomalies were identified in the returned lead portions.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• 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: 4723453
• MDR Text Key: 5748072
• Report Number: 1644487-2015-04537
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2015
• Device Model Number: 304-20
• Device Lot Number: 2900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2011
• 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): Required Intervention
• Patient Age: 62 YR