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

Model Number 105

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Seizures, Grand-Mal (2168); Coma (2417)

Event Date 01/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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 Description

Multiple requests for additional relevant information have been unsuccessful to date.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5399489
• MDR Text Key: 37485491
• Report Number: 1644487-2016-00153
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/12/2016
• Device Model Number: 105
• Device Lot Number: 203191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR