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MAUDE Adverse Event Report

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CYBERONICS, INC. VNS THERAPY PULSE PULSE GENERATOR   Back to Search Results
Model Number 102
Event Date 07/02/2003
Event Type  Injury   Patient Outcome  Life Threatening; Required Intervention
Event Description

Reporter indicated that vns patient has experienced an increase in seizures since stimulation was initiated. It was reported that before vns therapy, the patient had 7 - 8 petit mal seizures per month and that post therapy, patient has 3 - 4 petit mal seizures per day. Treating neurologist indicated that the patient had requested a reduction in programmed parameters due to the increase in seizures. Neurologist indicated that the increase was possibly related to the vns therapy.

 
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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. ste. 600
houston TX 77058
Manufacturer Contact
darlene garner, rac
100 cyberonics blvd., ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key467412
MDR Report Key478603
Event Key453631
Report Number1644487-2003-00486
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Patient
Type of Report Initial
Report Date 07/18/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/15/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date03/31/2005
Device MODEL Number102
Device LOT Number8125
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/18/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2003
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: 08/15/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,MODEL 302-20 VNS THERAPY LEAD,
2,EXPIR DATE 04/30/2005, DATE OF MFG 04/16/2003,
3,STERILIZATION LOT NO. 8237.
 
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