MAUDE Adverse Event Report: CYBERONICS, INC.PULSE GEN MODEL 102

Model Number 102

Event Date 06/27/2008

Event Type  Death   Patient Outcome  Death

Event Description

It was reported that the vns epilepsy pt passed away. The physician informed the mfr that the cause of death was sudep. Treating physician reported that the pt's generator was inadvertently programmed off and determined that the pt was without vns therapy for approx 5 months (refer to mfg report # 1644487-2008-01741). Pt's device was then programmed back on to 0. 5ma. The pt passed away the following day. An autopsy was performed. The treating physician reported that death was not related to vns therapy. Pt's generator and lead were explanted after death and returned to the mfr. Analysis on the returned generator has been completed. There were no performance or any adverse conditions found with the pulse generator during lab analysis. Prod analysis on the explanted lead is pending. Good faith attempts to obtain autopsy results and programming history have been unsuccessful to date.

• Brand Name: PULSE GEN MODEL 102
• Manufacturer (Section F): CYBERONICS, INC.; houston TX 77058
• Manufacturer (Section D): CYBERONICS, INC.; houston TX 77058
• Manufacturer Contact: michael carroll ; 100 cyberonics blvd.; ste. 600; houston , TX 77058; (281) 228 -7200
• Device Event Key: 1070718
• MDR Report Key: 1091663
• Event Key: 1049194
• Report Number: 1644487-2008-01735
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2008

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/31/2008
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device EXPIRATION Date: 09/30/2007
• Device MODEL Number: 102
• Device LOT Number: 014188
• Was Device Available For Evaluation?: Yes
• Date Returned to Manufacturer: 07/11/2008
• Is The Reporter A Health Professional?: Yes
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 07/03/2008
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 10/01/2005
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: No

Is this an Explanted Device?

• Type of Device Usage: Initial