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. PULSE GEN MODEL 102   Back to Search Results
Model Number 102
Event Date 05/01/2007
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Reporter indicated that a vns pt experienced an increase in seizures above previous baseline. The physician also indicated the seizures were more severe. The pt's vns device was programmed off, and the seizures decreased and were less severe. Device diagnostics showed vns to be functioning properly.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
michael carroll
100 cyberonics blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key1041068
MDR Report Key1071636
Event Key860654
Report Number1644487-2008-01571
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 06/30/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/09/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date03/31/2008
Device MODEL Number102
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 Received06/30/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2006
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

 
-
-
-
-
-