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

Model Number 304-20

Device Problem Fracture (1260)

Patient Problem Neck Pain (2433)

Event Date 09/01/2017

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2017 that a vns patient has high lead impedance.System diagnostics taken on (b)(6) 2017 showed impedance greater than 10,000 ohms.The patient did not complain of pain or changes of seizure control in clinic but the patient¿s caregiver noted he complained of neck pain several days ago.The device was not disabled since the patient was still getting benefits from the device.The pain was not stimulation related according to the patient.However, it is likely that the pain is related to the lead fracture and may be due to residual pain from the stimulation.Surgical intervention has not occurred to date.

Event Description

Information was received that the explanting did not return the products or provide them to the sales representative for return.The hospital's policy is to dispose of the explanted products at that hospital.No additional or relevant information has been received to date.

Event Description

An implant card was received stating that the patient had a full replacement due to high impedance.The explanted devices were discarded and are not available for return.No additional or relevant information has been received to date.

Event Description

Information was received that a user facility medwatch report was submitted.The medwatch states that the explanted devices will be returned to the manufacturer although no products have been received to date.(b)(4).No additional or relevant information has 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: 6900580
• MDR Text Key: 87632376
• Report Number: 1644487-2017-04515
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2013
• Device Model Number: 304-20
• Device Lot Number: 201164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 7 YR
• Event Location: Other
• Date Manufacturer Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2009
• 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: 51 YR