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

Model Number 304-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 03/01/2015

Event Type  malfunction  

Event Description

It was reported on 04/22/2015 from the physician's office that the patient's notes say that the wire was positioned more towards the sternocleidomastoid muscle than the vagus nerve which caused the muscle spasm.This was thought to be just due to the placement of the device and not any trauma or manipulation.The replacement surgery did correct the issue according to the nurse.

Event Description

On 06/09/2015 it was reported that the ent surgeon who performed the patient's replacement surgery on (b)(6) 2015 believes that the original surgeon did not properly place the leads in his opinion.

Event Description

It was reported that the neurologist suspects that the wire is not on the vagus nerve due to left anterior muscle contractions upon stimulation anytime he tries to have higher stimulation.The physician also stated that the patient is a large man and he thinks that it is odd that he can see the lead wire so easily.Upon consult with the physician and surgeon it was decided that the patient will receive a full revision.Patient underwent a full replacement on (b)(6) 2015.The explanted products are not available fro return based on the explanting facility's protocols.Attempts for additional information have been made and have been unsuccessful to date.

Manufacturer Narrative

Event Description

The surgeon who revised the patient's lead in april mentioned that the patient's neck would severely contract and there was lack of strain relief seen in the lead device.Once the patient was revised in april there have been no issues.

• 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: 4714190
• MDR Text Key: 5742331
• Report Number: 1644487-2015-04513
• 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,Followup,Followup
• Report Date: 03/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Model Number: 304-20
• Device Lot Number: 202577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2013
• 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: 44 YR