MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Seizures (2063)

Event Date 11/14/2016

Event Type  malfunction  

Event Description

Patient reports that she began having an increase in seizures 3 days ago ((b)(6) 2016) and thinks it is related to the device.Patient stated that she just saw her neurologist, who checked the device and said everything was fine.The patient believes that the output current needs to be increased.Additional information was received that the patient was seen on (b)(6) 2016 and that the vns device was found to be functioning normally by the physician at that time.Patient mentioned that she was doing better on (b)(6) 2016.The nurse offered an appointment on (b)(6) 2016 to check the vns device if needed but the patient mentioned that she was okay and can wait for the pre-scheduled appointment on (b)(6) 2016.Patient is to have the device turned off on (b)(6) 2016 for an mri and turn it back on later.The nurse did not know the seizure level on how it compared to pre-vns baseline and was not sure if the seizures were elated vns or not.The mri was scheduled to see if the patient's seizures are due to multiple sclerosis (ms) or possibly vns.Patient's device was checked on (b)(6) 2016 and patient was doing well in regards to seizures at that time.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6160025
• MDR Text Key: 62339382
• Report Number: 1644487-2016-02833
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2014
• Device Model Number: 103
• Device Lot Number: 3546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2013
• 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