MAUDE Adverse Event Report: CYBERONICS, INC.NEUROCYBERNETIC PROSTHESISVAGAL NERVE STIMULATOR GENERATOR

Model Number 100

Event Type  Injury   Patient Outcome  Hospitalization,Life Threatening

Event Description

Pt had a cyberonics vagal nerve stimulator implanted 2 wks ago. Stimulator turned on 10/18/1999. Pt had an acute mi 3-4 hrs later.

• Brand Name: NEUROCYBERNETIC PROSTHESIS
• Type of Device: VAGAL NERVE STIMULATOR GENERATOR
• Baseline Brand Name: NCP PULSE GENERATOR
• Baseline Generic Name: PULSE GENERATOR
• Baseline Catalogue Number: NA
• Baseline Model Number: 100
• Baseline Device Family: NA
• Baseline Device PMA Number: P970003
• Baseline Shelf Life Information: Yes
• Is Baseline 510(K) Number Provided?: No
• Baseline Preamendment?: No
• Transitional?: No
• 510(K) Exempt?: No
• Shelf Life(Months): 18
• Date First Marketed: 07/16/1997
• Manufacturer (Section F): CYBERONICS, INC.; 16511 space center blvd.; suite 600; houston TX 77058
• Manufacturer (Section D): CYBERONICS, INC.; 16511 space center blvd.; suite 600; houston TX 77058
• Device Event Key: 237906
• MDR Report Key: 245555
• Event Key: 230347
• Report Number: MW1017365
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/1999
• 2 DeviceS WERE Involved in the Event: 1 2

1 Patient Was Involved in the Event

• Date FDA Received: 10/20/1999
• Is This An Adverse Event Report?: No
• Device Operator: Health Professional
• Device EXPIRATION Date: 01/01/2001
• Device MODEL Number: 100
• Device LOT Number: 26853C
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Event Location: Other
• Was The Report Sent To Manufacturer?: Yes
• Is the Device an Implant?: Yes

Is this an Explanted Device?

Patient TREATMENT DATA

Date Received: 10/20/1999 Patient Sequence Number: 1

#	Treatment	Treatment Date
DILANTIN 400MG/D
NEURONTIN 3600MG/D