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

Model Number 103

Device Problems Unexpected Therapeutic Results (1631); Low Battery (2584)

Patient Problem Seizures (2063)

Event Date 08/01/2016

Event Type  Injury  

Event Description

It was reported by the physician that the patient will be referred for replacement as the vns battery was low and the patient had an increase in seizures.A battery life calculation was performed which showed the generator had approximately 1.4 years remaining until the generator would reach the neos = yes (near end of service) condition.Additional information was provided by the physician's office in regards to the low battery and increased seizures.It was noted the patient's seizures were stable until (b)(6) 2016, but it was unknown if this increase was below or above the patient's pre-vns baseline levels.It was also noted the generator was showing about 10%-15% battery life remaining and the battery indicator was yellow, indicating an ifi = yes (intensified follow-up indicator) condition.It was stated there was no obvious reason for the increased seizures.No known surgical interventions have occurred to date.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was later reported the patient underwent generator replacement surgery due to prophylactic replacement.

Event Description

It was further reported by the physician's office that it appears the patient's increase in seizures was at or below pre-vns baseline; however, it was explained the caregivers at the patient's living facility would have a better idea.The caregivers at the patient's living facility noted they were unable to determine the patient's pre-vns baseline levels, but there were not medication changes, illnesses, or other external stressors that were believed to cause or contribute to the increase in seizures.It was noted the increase in seizures appears to be related to the low vns battery.

Event Description

The generator was received by the manufacturer for analysis.While analysis is expected, it has not been completed to date.

Manufacturer Narrative

(b)(4).

Event Description

Product analysis (pa) was completed.Although the reported allegation of increased seizures could not be evaluated in the (b)(4) laboratory setting, proper functionality of the generator in its ability to provide appropriate programmed output currents can be verified.This was successfully verified in the (b)(4) lab.During analysis, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The generator diagnostics were as expected for the programmed parameters.Electrical evaluation showed the generator performed according to functional specifications.There were no performance, or any other types of adverse conditions found with the generator.

• 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: 6135440
• MDR Text Key: 61138389
• Report Number: 1644487-2016-02750
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/08/2017

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: 11/30/2011
• Device Model Number: 103
• Device Lot Number: 2620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/24/2017; 01/24/2017; 02/28/2017; 03/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2010
• 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: 38 YR