MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problems High impedance (1291); Device Displays Incorrect Message (2591)

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 10/26/2016

Event Type  malfunction  

Event Description

It was reported within clinic notes date (b)(6) 2016 that the patient had a notable increase in seizures over the last 2 months when they were previously stable.The number of seizures still seemed to be less than the pre-vns baseline value; however, it was noted there was a warning message when checking the vns which showed high impedance.The vns was not programmed off after the high impedance was observed.Additionally, the patient was could not feel the device stimulating anymore.An implant card was later received which showed the patient's revision surgery occurred on (b)(6) 2016.Attempts for additional relevant information have been unsuccessful to date.

Event Description

It was later reported by the physician's office that if the physician left the patient programmed on, it would have been due to the patient's severe epilepsy and there would be a greater risk in programming the vns off.Additionally, it was noted when the vns was working correctly, the patient would have 1 to 2 seizures per month.The seizures were shorter, less severe, and caused less injuries then prior to vns.When the device began to malfunction, the patient's seizures went up to 4 to 5 seizures per month.The patient's pre-vns baseline level was explanted to be 4-8 seizures per month, which were longer, more severe, and caused more injuries.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: 6116994
• MDR Text Key: 60865718
• Report Number: 1644487-2016-02689
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2014
• Device Model Number: 302-20
• Device Lot Number: 2542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2010
• 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: 46 YR