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

Model Number (11)150331

Device Problem Circuit Failure (1089)

Patient Problem Burning Sensation (2146)

Event Date 08/19/2016

Event Type  Injury  

Event 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
• Type of Device: VAGUS NERVE STIMULATOR
• Manufacturer (Section D): CYBERONICS
• MDR Report Key: 7424951
• MDR Text Key: 105453386
• Report Number: MW5076446
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750252
• UDI-Public: (01)05425025750252
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2018
• Device Model Number: (11)150331
• Device Lot Number: 1464006
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 16 YR
• Patient Weight: 57