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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 12/11/2002
Event Type  Injury   Patient Outcome  Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative

Report is incomplete because no response has been received to manufacturer's request for additional information from treating neurologist.

 
Event Description

Vns patient's seizures are worse following vns implant. It was reported that the patient has experienced an increase in the number of seizures. The patient reportedly had a recent seizure during which they blacked-out and fell. The patient subsequently underwent ear surgery because they damaged their ear during the fall. The patient reported that they did have black-outs prior to vns implant.

 
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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.
suite 600
houston TX 77058 2017
Manufacturer Contact
darlene garner, rac
100 cyberonics blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key462703
MDR Report Key473853
Event Key449145
Report Number1644487-2003-00441
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 06/25/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date11/30/2003
Device MODEL Number102
Device LOT Number6193
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/25/2003
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: 07/24/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,MODEL 302-20 VNS THERAPY LEAD
2,EXPIR DATE 09/30/2004
3,DATE OF MFG 09/24/2002, STERILIZATION LOT NO. 7083
 
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