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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 11/01/2002
Event Type  Injury   Patient Outcome  Life Threatening;
Manufacturer Narrative

Report is incomplete because attempt to obtain additional information has been unsuccessful to date.

 
Event Description

Patient has had an increase in seizures since their implant. The patient had been having 1 seizure every month or every other month and is now having 2-3 seizures a month.

 
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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 Key437090
MDR Report Key448108
Event Key424294
Report Number1644487-2003-00091
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 02/12/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/13/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date12/31/2003
Device MODEL Number102
Device LOT Number6267
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/12/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2002
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/13/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,MODEL 302-20 VNS THERAPY LEAD, EXPIR 09/30/2004,
2,DATE OF MFG 9/25/2002, STERILIZATION LOT NO. 7083.
 
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