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

Model Number 302-30

Device Problems High impedance (1291); Battery Problem (2885)

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

Event Date 04/25/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient was referred for surgery due to high impedance and end of service.No known interventions have occurred to date.Attempts for additional relevant information have been unsuccessful to date.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2010.

Manufacturer Narrative

Review of the available programming and diagnostic history.Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description

Additional information was received indicating that the vns patient was tested multiple times during an office visit on 04/25/2014 and diagnostic results revealed high impedance (impedance value >= 10,000 ohms).The neurologist was unaware of any trauma that may have caused or contributed to the reported high impedance.The patient was referred for surgery but the patient declined replacing her device.According to the patient¿s husband, the patient never received efficacy with vns.The husband stated that the patient had been seizure free for two months using a new medication.According to the neurologist, there was no lack of efficacy with vns for the patient.No known surgical interventions have occurred to date.

Manufacturer Narrative

Date of event; corrected data: additional information indicates that the date of event was (b)(6) 2014.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: 3826482
• MDR Text Key: 4452792
• Report Number: 1644487-2014-01351
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2014

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: 10/31/2005
• Device Model Number: 302-30
• Device Lot Number: 009342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/09/2014
• Initial Date FDA Received: 05/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2003
• 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: 65 YR