MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Seizures (2063)

Event Date 05/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient had a seizure lasting four minutes that required the use of diastat on (b)(6) 2016.This was the first seizure the patient had since (b)(6) 2016.The patient had recently had a dosing appointment on (b)(6) 2016, and his output current was increased from 2.0ma to 2.25ma.It was reported that the caregiver believed that the seizure may have been due to the increased output current.However, the patient had not had another seizure since (b)(6) 2016, so she was no longer sure that the seizure was related to the increased output current.The patient had a dramatic decrease in seizures since he had vns implanted.The patient also had another seizure on (b)(6) 2016, and diastat had to be used again.The caregiver believed that the higher normal mode setting may have caused excessive coughing that led to the seizure on (b)(6) 2016.The physician reduced the output current because of the coughing with stimulation.No further relevant information has been received to date.

Event Description

The physician could not determine if the seizure on (b)(6) 2016 was related to the increase in output current because the patient had seizures in the past.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 5734276
• MDR Text Key: 47703917
• Report Number: 1644487-2016-01387
• 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 Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 05/20/2016

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/09/2017
• Device Model Number: 103
• Device Lot Number: 4273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/20/2016
• Initial Date FDA Received: 06/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2015
• 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 Outcome(s): Other
• Patient Age: 56 YR