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

Event Date 07/01/2008

Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization

Event Description

Reporter indicated a vns pt "developed intractable psychosis after the use of a vns device for treatment of his refractory epilepsy". Although he had a prior history of psychotic illness, the episode reported here was significantly more severe in terms of the content of the delusions, the tenacity with which they were maintained, the explosive violence and the refractoriness to antipsychotic medication. The improvement in his condition following each reduction in vns pulse intensity was swift and dramatic. Good faith attempts to obtain additional info have been unsuccessful to date.

Manufacturer Narrative

Keller, s. , md, & lichtenberg, p, md (july 2006) psychotic exacerbation in a pt with seizure disorder treated with vagas nerve stimulation. Imaj 2008-10:550-551.

• Brand Name: PULSE GEN MODEL UNK
• Manufacturer (Section F): CYBERONICS, INC.; houston TX
• Manufacturer (Section D): CYBERONICS, INC.; houston TX
• Manufacturer Contact: nydia grimes ; 100 cyberonics blvd.; ste 600; houston , TX 77058; (281) 228 -7200
• Device Event Key: 1225562
• MDR Report Key: 1186054
• Event Key: 1136584
• Report Number: 1644487-2008-02417
• 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: 09/05/2008

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/03/2008
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 09/05/2008
• 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