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

Model Number 102

Event Date 06/01/2008

Event Type  Injury   Patient Outcome  Other

Event Description

Initial reporter indicated that the pt had manic episodes after the device was turned on about two weeks after implant in 2008. Physician stated that "pt had no previous psychiatric history. Family reported that pt has high elevated moods (being too happy) and had uncontrollable giggling and laughing. " additionally, reported "when pt first came into the appointment, he was quite reserved, but after awhile he was being quite talkative and kept on saying he's 1 years old. " pt was at 0. 25ma, 30, 500, 30sec, 5min, magnet 0. 5ma, 500 and so physician turned the device to 0ma. After that, the pt calmed down and slept a lot. A week later, the physician turned pt back up to 0. 25, 30, 500, 30sec, and 20 min off. The pt is reported to be doing fine currently.

• Brand Name: GEN MODEL 102
• Manufacturer (Section F): CYBERONICS, INC.; houston TX 77058
• Manufacturer (Section D): CYBERONICS, INC.; houston TX 77058

Manufacturer (Section G)

• Manufacturer Contact: michelle carroll ; 100 cyberonics blvd., ste. 600; houston , TX 77058- ; (281) 228 -7200
• Device Event Key: 1075937
• MDR Report Key: 1098144
• Event Key: 1055175
• Report Number: 1644487-2008-01781
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2008

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/04/2008
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device MODEL Number: 102
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 07/08/2008
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• 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?

• Type of Device Usage: Initial