MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Under-Sensing (1661)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/07/2016

Event Type  malfunction  

Event Description

A patient reported that he did not believe his vns device was not responding to heart rate as intended.The patient information regarding his seizure log and reported that the vns device was not helping his seizure rate.His vns settings were provided and showed that the patient's device had not been programmed to therapeutic levels since implant.Attempts to obtain programming and diagnostic data from the physician have been made with no success to date.A review of the device history record for the implanted generator was performed and verified that the generator had passed all quality inspections prior to release for distribution.

Event Description

Follow-up was performed with the patient's neurologist.The neurologist indicated that she had seen the patient in a more recent clinic visit and the device was reportedly working as intended.The patient's device was not having any reported heart rate sensing issues and there were no historical notes from the physician stating they had sensing issues.

Manufacturer Narrative

Device evaluated by manufacturer, additional information: a full analysis of this event is not required for this event as the event has been confirmed invalid through the methods performed to date.

Event Description

Programming data was provided to the manufacturer and the provided data showed indications of proper device functionality throughout the entire provided history.The patient's heartrate appeared to be accurately measured in all instances and the number of autostimulations provided showed indications that the device was reacting to the increases in heart rate.

• Brand Name: PULSE GEN MODEL 106
• 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: 6192910
• MDR Text Key: 62958494
• Report Number: 1644487-2016-02925
• 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,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/04/2018
• Device Model Number: 106
• Device Lot Number: 4696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2016
• 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: 64 YR