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

Model Number 302-20

Device Problems High impedance (1291); Patient Lead (3079)

Patient Problems Headache (1880); Pain (1994)

Event Date 01/17/2011

Event Type  Malfunction  

Event Description

It was reported by a vns pt that she experienced sharp pain in her neck when turning her head along with headaches with pain over her right eye. Add'l info was received from a company rep indicating the pt's treating neurologist had in his notes from (b)(6) 2010 that high impedance was noted. Follow-up was made with the pt treating neurologist and nurse. The nurse indicated that the pt was taken to an mri and results were normal for the pain and headaches, hence she did not know what caused the pain and headaches. No x-rays were taken for the reported high lead impedance and it was unk if pt manipulation or trauma contributed to the reported high lead impedance. Current plans were to increase the pt's vimpat and follow-up in 3 months as the pt's battery is dead. Review of the manufacturer's programming history database was not indicative of high lead impedance although history was limited to (b)(4) 2005.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

• Brand Name: LEAD MODEL 302
• Manufacturer (Section D): CYBERONICS, INC.; houston TX 77058
• Manufacturer Contact: nydia grimes ; 100 cyberonics blvd.; ste. 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 2036841
• MDR Text Key: 1892289
• Report Number: 1644487-2011-00276
• 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: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/17/2011

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 02/16/2011
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 03/31/2008
• Device MODEL Number: 302-20
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Date Manufacturer Received: 01/17/2011
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 04/01/2005
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial