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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC.NEUROCYBERNETIC PROSTHESISVAGAL NERVE STIMULATOR GENERATOR

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CYBERONICS, INC. NEUROCYBERNETIC PROSTHESIS VAGAL NERVE STIMULATOR GENERATOR   Back to Search Results
Model Number 100
Event Type  Injury   Patient Outcome  Hospitalization,Life Threatening
Event Description

Pt had a cyberonics vagal nerve stimulator implanted 2 wks ago. Stimulator turned on 10/18/1999. Pt had an acute mi 3-4 hrs later.

 
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Brand NameNEUROCYBERNETIC PROSTHESIS
Type of DeviceVAGAL NERVE STIMULATOR GENERATOR
Baseline Brand NameNCP PULSE GENERATOR
Baseline Generic NamePULSE GENERATOR
Baseline Catalogue NumberNA
Baseline Model Number100
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)18
Date First Marketed07/16/1997
Manufacturer (Section F)
CYBERONICS, INC.
16511 space center blvd.
suite 600
houston TX 77058
Manufacturer (Section D)
CYBERONICS, INC.
16511 space center blvd.
suite 600
houston TX 77058
Device Event Key237906
MDR Report Key245555
Event Key230347
Report NumberMW1017365
Device Sequence Number1
Product CodeLYJ
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 10/19/1999
2 DeviceS WERE Involved in the Event:1 2 
1 Patient Was Involved in the Event
Date FDA Received10/20/1999
Is This An Adverse Event Report? No
Device Operator Health Professional
Device EXPIRATION Date01/01/2001
Device MODEL Number100
Device LOT Number26853C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Was The Report Sent To Manufacturer? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 10/20/1999 Patient Sequence Number: 1
#TreatmentTreatment Date
DILANTIN 400MG/D
NEURONTIN 3600MG/D
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