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

Model Number 103

Device Problems Energy Output To Patient Tissue Incorrect (1209); Battery Problem (2885)

Patient Problems Seizures (2063); No Code Available (3191)

Event Date 06/01/2016

Event Type  malfunction  

Event Description

It was reported by a physician that a vns patient was doing well with vns therapy, but had been having more seizures and felt his vns is not working.The physician reviewed a chest x-ray and stated everything looked good, lead impedance was fine at 1700 ohms, and his battery life is steadily decreasing appropriately.The physician noted that the output current and magnet output current were set to the same settings after he adjusted them in (b)(6) 2016, which was after the symptoms first appeared.Additional relevant information has not been received to-date.

Event Description

Follow-up to the provider¿s office by the company representative indicated that after they had called the patient, he is doing better and was not having any seizures.

Event Description

Later follow-up from the physician provided that the patient was concerned his vns was not firing consistently.The patient reported that in the past his voice would change with each vns stimulation.However, over the last 6 months he is not noticing consistent voice changes.Interrogation of the device showed it was in working order.It was provided the patient attempts to stimulate the device with the magnet multiple times throughout the day to make sure his vns is working, but the activations were not showing up after checking the device.The battery life was stated to be at approximately 85-90% at the time of the report.

Event Description

Follow-up to the company representative who attended the patient¿s appointment provided that the physician explained to the patient that over time the stimulation sensation may go away over time to where he may not feel it ¿firing¿ or ¿going off¿ anymore or at all.The physician also discussed that he checks diagnostics to ensure his device is working properly and at this point in time he has no concerns at all.

• 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: 6037714
• MDR Text Key: 57869180
• Report Number: 1644487-2016-02396
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2016
• Device Model Number: 103
• Device Lot Number: 202862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2014
• 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): Other
• Patient Age: 48 YR