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

Model Number 102

Event Date 01/01/2006

Event Type  Injury   Patient Outcome  Required Intervention

Event Description

Reporter indicated that he started experiencing manic episodes approx 1 month following the implant of the vns therapy system. Reporter stated he was then prescribed lithium by his dr, and that the mania subsided with the daily use of this medication.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: MUZ
• Manufacturer (Section F): CYBERONICS, INC.; houston TX 77058
• Manufacturer (Section D): CYBERONICS, INC.; houston TX 77058
• Manufacturer Contact: donnie welty, rn, bsn ; 100 cyberonics blvd.; ste. 600; houston , TX 77058; (281) 228 -7200
• Device Event Key: 823699
• MDR Report Key: 836404
• Event Key: 799295
• Report Number: 1644487-2007-00160
• Device Sequence Number: 1
• Product Code: MUZ
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: NOT APPLICABLE
• Type of Report: Initial
• Report Date: 02/07/2007

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 04/11/2007
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device EXPIRATION Date: 06/30/2007
• Device MODEL Number: 102
• Device LOT Number: 013620
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2007
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 08/01/2005
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: Yes
• Is this an Explanted Device?: No Answer Provided
• Type of Device Usage: Initial