• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

CYBERONICS, INC. PULSE GEN MODEL UNK Back to Search Results
Event Date 07/01/2008
Event Type  Injury  
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE 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 Key1225562
MDR Report Key1186054
Event Key1136584
Report Number1644487-2008-02417
Device Sequence Number1
Product CodeLYJ
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 Received10/03/2008
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 Received09/05/2008
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

Patient TREATMENT DATA
Date Received: 10/03/2008 Patient Sequence Number: 1
-
-