MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number	105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Pain (1994); Seizures, Grand-Mal (2168); Coma (2417)
Date of Event	01/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
A patient reported that he has been experiencing painful stimulation in his chest and side, and an increase in seizure activity, following being in a coma for 3 days (coma was stated to be due to a grand mal seizure).The patient was subsequently seen by a new treating neurologist in (b)(6) 2016 and it was reported that the patient's vns system showed a normal lead impedance and battery status.Vns device parameters were adjusted to address the reported painful stimulation.A review of available programming and diagnostic history revealed no anomalies.
Event or Problem Description
Multiple requests for additional relevant information have been unsuccessful to date.

• Brand Name: PULSE GEN MODEL 105
• Common Device Name: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 5399489
• Report Number: 1644487-2016-00153
• Device Sequence Number: 539354
• Product Code: LYJ
• Combination Product (Y/N): N
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2016

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/12/2016
• Device Model Number: 105
• Device Lot Number: 203191
• Was Device Available for Evaluation?: No
• Event Location: Other
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2016
• Supplement Report FDA Received Date: 03/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR