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. VNS THERAPY PULSE PULSE GENERATOR   Back to Search Results
Model Number 102
Event Date 03/01/2004
Event Type  Injury   Patient Outcome  Life Threatening;
Event Description

Reporter indicated that pt has recently experienced an increase in seizures. It was reported that the pt experienced 1-2 seizures per year prior to vns implant and that pt recently experienced 3 seizures within one month. Treating neurologist indicated that the pt was doing fine and that the reported event was not related to the vns. The pt's seizures types had not changed. The pt's health condition is reportedly not worsening and there were no environmetal stimuli that may have contributed to the increase in seizure activity. Neurologist indicated that programming the pt's device to off resulted in no change to the pt's condition or symptoms.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVNS THERAPY PULSE
Type of DevicePULSE GENERATOR
Baseline Brand NameVNS THERAPY PULSE
Baseline Generic NamePULSE GENERATOR
Baseline Catalogue NumberNA
Baseline Model Number102
Baseline Device FamilyNA
Baseline Device PMA NumberP970003
Baseline Shelf Life Information Yes
Is Baseline 510(K) Number Provided? No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed06/20/2002
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd.
suite 600
houston TX 77058
Manufacturer Contact
darlene garner, rac
100 cyberonics blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key511773
MDR Report Key522645
Event Key496020
Report Number1644487-2004-00365
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Patient
Type of Report Initial
Report Date 03/30/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date01/31/2005
Device MODEL Number102
Device LOT Number7811
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/30/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2003
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: 04/28/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
1,MODEL 302-20 VNS THERAPY LEAD, EXPIR DATE
2,03/31/2005, DATE OF MFG 03/10/2003,
3,STERILIZATION LOT NO. 8010.
 
-
-
-
-
-