MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Insufficient Information (3190)

Patient Problem Seizures (2063)

Event Date 12/23/2015

Event Type  malfunction  

Event Description

The patient reported that she is experiencing an increase in seizures as well as change in seizure pattern.She now states that her seizures appear to have an abdominal component as her stomach is upset with her seizures.No additional relevant information has been received to date.

Event Description

It was reported that the patient is concerned that her vns may need replacement due to seizure activity.She believes her current output current is 3.5 ma.No additional relevant information has been received to date.

Event Description

Patient reported that she has been having breakthrough seizures and is wondering if her vns is going out.Patient also said that she has been sick with the flu and is not eating.Patient also mentioned that her magnet is not working as well.No additional relevant information has been received.

Event Description

The physician reported the patient's settings and diagnostics and the device was functioning properly.The physician does not believe the increase in seizures for the patient is related to the vns but rather environmental or social factors.The patient was given new magnets and was shown the proper technique for activating the device.The magnet activation was shown to provide stimulation as intended.

• Brand Name: PULSE GEN MODEL 105
• 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: 5370584
• MDR Text Key: 36477929
• Report Number: 1644487-2016-00117
• 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,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2014
• Device Model Number: 105
• Device Lot Number: 202019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2012
• 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: 51 YR