MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-20

Device Problem Fracture (1260)

Patient Problems Chest Pain (1776); Pain (1994)

Event Date 06/01/2019

Event Type  malfunction  

Event Description

It was reported by the sales rep that the patient reported increase chest pain and was referred to see the surgeon.X-rays were sent in for prompt review.The x-rays were reviewed and the generator placement was determined in the left chest.Based on the scope of the image, the feed through wires were intact and the pin could be visualized passed the second connector pin per the scope and angle of the image.The lead was visualized in the chest and neck.The strain relief bend could be visualized, however due to the scope and quality of the image it could not be determined is a strain relief loop was present.Two tie downs were present however based on the scope and quality of the image it could not be determined if they were placed per labeling.The lead did not appear to be routed behind the generator; however this could not be properly assessed due to the quality of the image.The lead wires at the connector pin appeared to be intact but the lead appear to be twisted sharply near rib 2.The lead was assessed for fractures and no gross fractures or discontinuities were noted.Based on the x-rays received, and the quality and scope of the images, the cause for the chest pain could not be determined at this time.Information was later received from the physician's office indicating that the patient's pain began around june around vns site but is not constant.The cause of the pain was indicated to be unknown.It was indicated that at that time there was no plan for intervention to be taken and the patient would continue to be monitored and follow-up with neurosurgery as needed if pain persists.An implant and warranty card was later received indicating the patient received a full revision due to a lead fracture.Per the surgeon, the patient complained of shocking sensations but there was no note of high lead impedance.The facility the revision took place does not return explants, therefore the explanted product is not available for product analysis.No additional 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9128897
• MDR Text Key: 160491215
• Report Number: 1644487-2019-01887
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/07/2012
• Device Model Number: 302-20
• Device Lot Number: 201071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2009
• 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: 17 YR