• 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 UNKNOWN

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

CYBERONICS, INC. PULSE GEN MODEL UNKNOWN   Back to Search Results
Event Date 01/01/2004
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported that the pt experienced psychosis in 2004 which was believed to be directly related to stimulation. The physician indicated that the pt's seizures were well-controlled by vns, however, the pt had psychotic episodes involving the desire to kill his parents. The physician indicated that the device was programmed off and the psychosis subsided. At a later date, the physician wanted to program the pt's vns device back on, however, the mother was adamant that it not be turned on due to the harm the pt may try to cause her.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL UNKNOWN
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 Key1709775
MDR Report Key1667284
Event Key1584174
Report Number1644487-2010-01000
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/25/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/23/2010
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 Manufacturer? No
Date Manufacturer Received03/25/2010
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? No
Is this an Explanted Device?
Type of Device Usage Initial

-
-