MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem Low Battery (2584)

Patient Problem Seizures (2063)

Event Date 01/01/2015

Event Type  malfunction  

Event Description

It was reported that the patient's seizures are worse at times, but it is unknown whether or not the increase is above the patient's pre-vns baseline frequency.The patient believes that the generator battery is low.The patient reported that she still feels device stimulation, but that the seizures are changing and are more frequent at night.The patient reported that she has not been seen by the physician for a year and needs to find a new physician to have the device checked.Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description

Additional information was received stating that the vns patient had scheduled an appointment with a new physician to check the device but then cancelled the appointment.The patient has not been seen by a physician to date.

Manufacturer Narrative

• Brand Name: PULSE GEN MODEL 104
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4627745
• MDR Text Key: 5573292
• Report Number: 1644487-2015-04220
• 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,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2011
• Device Model Number: 104
• Device Lot Number: 2309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2009
• 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: 45 YR