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MAUDE Adverse Event Report

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CYBERONICS, INC. PULSE GEN MODEL 102 LYJ   Back to Search Results
Model Number 102
Event Date 08/24/2005
Event Type  Injury   Patient Outcome  Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative

H6. Vns therapy system labeling states that the vns therapy device is not curative. Treating physician believes that there is a direct relationship between device stimulation and the reported events and that the vns therapy precipitated the nonconvulsive status epilepticus in this pt.

 
Event Description

Upon inititation of stimulation, the pt experienced more seizures than usual, requiring several emergency room visits for treatment of breakthrough seizures. Stimulation was initiated three weeks post implant and was discontinued approximately 5 months later due to the increase in seizure activity. It was reported that when stimulation was discontinued, the pt progressively returned to his previous neurological status (previous number of seizures per day). Two months after discontinuing stimulation, the device was programmed back to on, after which the pt developed several complex, partial, atonic, and generalized tonic-clonic seizures within 30 to 60 minutes. An eeg performed on that same day showed almost continuous bilateral epileptiform activity. The pt was subsequently admitted to the intensive care unit for treatment of nonconvulsive status epilepticus. The pt has no previous history of nonconvulsive status epilepticus. Changes to device settings were not attempted prior to discontinuation of stimulation because the treating physician believed that it was risky to keep the device prpgrammed to on. There were no medication changes at the time of the event and the pt is reportedly compliant with his antiepileptic medication regimen.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceLYJ
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.
houston TX *
Manufacturer Contact
donnie welty, rn, bsn
100 cyberonics blvd, ste 600
houston , TX 77058
(281) 228 -7200
Device Event Key713020
MDR Report Key723939
Event Key689363
Report Number1644487-2006-00213
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/19/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/07/2006
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date08/31/2005
Device MODEL Number102
Device LOT Number42565
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/19/2006
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2005
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

 
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