MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problem Seizures (2063)

Event Date 07/11/2015

Event Type  Injury  

Event Description

A provider indicated that a patient had experienced breakthrough seizures and was admitted to the hospital through the emergency room.No further information was provided.A battery life calculation performed revealed 9.4 years until neos = yes.Review of the available programming history indicated that the patient was implanted on (b)(6) 2006 and the device was programmed to a 0.3% duty cycle from the date of implant through at least (b)(6) 2010 while other parameters appear to have been titrated up in a typical manner through (b)(6) 2010.Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Review of the available programming and diagnostic history.

Event Description

Hospital records received indicate that the patient was admitted to the hospital on (b)(6) 2015 after presenting to the emergency room with a complaint of breakthrough seizures.The records indicate that the patient experienced two seizures at her group home on the day of admission and one additional seizure at another facility prior to presenting to the emergency room of the reporting hospital.The records state that the patient could not accurately describe her seizure frequency but the current seizures are stated to be her first in about a year.The records indicate that the patient can feel her device stimulation kicking in and device function was noted to be normal.The records indicate that the patient was given anti-seizure medication at the first facility and was prescribed an additional medication at the admitting facility.No additional interventions are described.The patient was discharged on (b)(6) 2015 with instructions to follow up with primary care physicians and neurologists.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Additional information received from the patient's neurologist indicates that the patient's breakthrough seizures were diagnosed as pseudoseizures due to stress and not likely related to vns.It was not known why the patient's device was programmed to a 0.3% duty cycle by prior providers, however, the current provider has elected not to increase the duty cycle as he is unclear regarding the patient's diagnosis of epilepsy and is referring the patient to another facility.The provider has not evaluated the patient's device since hospital discharge on (b)(6) 2015.

Manufacturer Narrative

Date received by manufacturer (mo/day/yr), corrected data: this information was inadvertently omitted from supplemental report #2.

• Brand Name: PULSE GEN MODEL 102
• 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: 4961348
• MDR Text Key: 6189713
• Report Number: 1644487-2015-05392
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2008
• Device Model Number: 102
• Device Lot Number: 015168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2006
• 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): Hospitalization
• Patient Age: 35 YR