MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-20

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

Patient Problems Neck Pain (2433); Fibrosis (3167); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/11/2022

Event Type  Injury  

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ;defects¿ or ;malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.(b)(4).

Event Description

It was reported that the patient had gained weight recently and enlargement of her breast which caused traction in the lead on the left side of the neck and the lead to be more prominent and restricting her neck movement.The patient had imaging done and the vns was confirmed to be intact and all values when checked were within normal limits.The patient requested to have repositioning surgery.During the surgery the surgeon noticed scar tissue and calcification around the lead that was dissected and then the lead was replaced.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 14837648
• MDR Text Key: 294870666
• Report Number: 1644487-2022-00770
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/18/2009
• Device Model Number: 302-20
• Device Lot Number: 1534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2006
• 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: 38 YR
• Patient Sex: Female