MAUDE Adverse Event Report: CYBERONICS VNS MAGNET MODEL 220; VAGUS NERVE STIMULATOR

Model Number	(11)150331
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	08/19/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Cyberonics vns magnet model 220 implant on (b)(6) 2016.(b)(6) 2016 device short circuited causing potential damage to vagal nerve.Patient felt extreme heat and could not move for 24 hours.Device then shut off, had to be surgically removed and replaced on (b)(6) 2016.Picture of malfunction device shows bubble that formed to interfere with wires.Device sent back to cyberonics.Lot number 1464006.

• Brand Name: VNS MAGNET MODEL 220
• Common Device Name: VAGUS NERVE STIMULATOR
• Manufacturer (Section D): CYBERONICS
• MDR Report Key: 7424951
• Report Number: MW5076446
• Device Sequence Number: 1950311
• Product Code: LYJ
• UDI-Device Identifier: 05425025750252
• UDI-Public: (01)05425025750252
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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?: Yes
• Operator of Device: No Information
• Device Expiration Date: 04/30/2018
• Device Model Number: (11)150331
• Device Lot Number: 1464006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 16 YR
• Patient Weight: 57