Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
-

MAUDE Adverse Event Report

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

CYBERONICS, INC. NI PULSE GENERATOR   Back to Search Results
Event Type  Injury   Patient Outcome  Life Threatening;
Event Description

Manufacturer became aware of a published clinical article summarizing the author's experience with vagus nerve stimulation as a neurophysiologic treatment for patients with refractory epilepsy. The article discusses a study on 15 epilepsy patients and indicates that 2 of 15 patients experienced an increase in seizure frequency with the vns therapy.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNI
Type of DevicePULSE GENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
houston TX *
Manufacturer Contact
darlene garner, rac
100 cyberonics blvd., ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key633234
MDR Report Key643726
Event Key612221
Report Number1644487-2005-00733
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Study,Literature,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/04/2005
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/31/2005
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/04/2005
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

 
-
-
-
-
-