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

Model Number 103

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

Patient Problem Seizures (2063)

Event Date 06/01/2015

Event Type  Injury  

Event Description

It was reported that the patient experienced a seizure that lasted 10-15 minutes after an increase in device settings.The patient was seen again by the physician at which time device settings were decreased back to the lowest settings.It is unknown if the seizure was related to vns therapy.The patient feels that vns has worked very well and made a significant different for her.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

Follow-up with the physician's office revealed that the patient was hysterical and always attributed her issues to vns.The physician's office did not believe any of the issues the patient had alleged were related to vns.The patient's seizure that was longer in duration was due to the patient's sickness at the time that was unrelated to vns.The patient's nausea and change in sleeping pattern were due to personal issues and stress.

Event Description

It was reported that the patient had a recent injury to the neck area and there was concern about lead fracture and increased seizures.The physician believed that the patient's issues are psychiatric in nature and reported that the vns is performing as intended.

• 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: 4910315
• MDR Text Key: 19030850
• Report Number: 1644487-2015-05175
• 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: Consumer,Health Professional,Company Representative,company representati
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2016
• Device Model Number: 103
• Device Lot Number: 203094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 56 YR