MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2018

Event Type  malfunction  

Event Description

It was reported that high impedance was identified on (b)(6) 2018 on the patient's device.The device was programmed off in response to the high impedance, and the patient was referred to the surgeon for x-rays.The surgeon planned to review the x-rays and decide the plan of action at that time.The patient recently had generator replacement surgery on (b)(6) 2017, and the settings were.Diagnostics were.The patient had not had any trauma to the site and falls, and he lived in a group home with one to one nursing care.The patient does have a trach, so it was possible that the trach could have pushed on the lead, albeit unlikely.The physician decided to review the x-rays himself, and they were not provided to the manufacturer.No surgery has occurred to date.

Event Description

It was reported that, due to the patient's overall health and medical issues, the surgeon was not going to replace the vns and would reassess the situation in the future based on the patient's condition.

• Brand Name: LEAD MODEL 304
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7463455
• MDR Text Key: 106609019
• Report Number: 1644487-2018-00657
• 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
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• 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: 202560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2013
• 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 Age: 9 YR