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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problems Seizures (2063); Anxiety (2328)

Event Date 09/01/2013

Event Type  malfunction  

Event Description

Product information was received.Additional information was received stating that the reported events did not appear to be related to vns.The patient was given medication for her anxiety.Clinic notes from the (b)(6) 2014 office visit did not indicate that there were any issues with the patient¿s device.

Manufacturer Narrative

Brand name, corrected data: previously submitted mdr indicated this information was unknown.It is now known.This report is being submitted to correct this data.Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated this information was unknown.It is now known.This report is being submitted to correct this data.Manufacture date, corrected data: previously submitted mdr indicated this information was unknown.It is now known.This report is being submitted to correct this data.

Event Description

It was reported that the vns patient¿s seizures began increasing in frequency, severity, and duration approximately six months ago.The patient was also experiencing an increase in anxiety and a decline in her mood.The neurologist decreased the device¿s off-time around that time.Attempts for additional relevant information were made but have been unsuccessful to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 3764818
• MDR Text Key: 4616814
• Report Number: 1644487-2014-01085
• 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 Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 103
• Device Lot Number: 202000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 04/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2012
• 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: 43 YR