MAUDE Adverse Event Report: CYBERONICS STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

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

Patient Problems Nausea (1970); Vomiting (2144)

Event Type  Injury  

Event Description

It was reported that the patient experienced vomiting and nausea.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): CYBERONICS
• MDR Report Key: 17526295
• MDR Text Key: 321137360
• Report Number: MW5133234
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2015

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1