MAUDE Adverse Event Report: CYBERONICS, INC. VAGUS NERVE STIMULATOR VNS THERAPY SYSTEM; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Model Number UNKNOWN VAGUS NERVE STIMULATOR

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

It was reported that the patient was having burr hole surgery for evacuation of subdural hematoma due to fall.Caller found it was a vagus nerve stimulator."this report reflects information received by fda in the form of a notification per 803.22 (b)(2)".

• Brand Name: VAGUS NERVE STIMULATOR VNS THERAPY SYSTEM
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): CYBERONICS, INC.
• MDR Report Key: 18183236
• MDR Text Key: 328797560
• Report Number: MW5148349
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UNKNOWN VAGUS NERVE STIMULATOR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2023
• Patient Sequence Number: 1