MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL UNK

Device Problem Insufficient Information (3190)

Patient Problem Fibrosis (3167)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

It was reported via an internet forum by an unknown patient that the physician observed their vns device "wasn't working for some reason." the patient was referred for exploratory surgery due to the issue with the device.During the exploratory surgery it was found that scar tissue had developed around the generator and lead.The lead and generator were both replaced at that time and the generator was noted to be at a low battery condition.No additional relevant information had been received to date.Following the surgery, the patient experienced issues with vocal cord paralysis and aspiration.These events were reported in mfg report # 1644487-2017-04147.

• Brand Name: LEAD MODEL UNK
• 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: 6724349
• MDR Text Key: 80405904
• Report Number: 1644487-2017-04146
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/22/2017
• Initial Date FDA Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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