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MAUDE Adverse Event Report

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CYBERONICS, INC. PULSE GEN MODEL 102   Back to Search Results
Model Number 102
Event Date 01/08/2007
Event Type  Death   Patient Outcome  Other;
Event Description

Initial reporter indicated that a vns pt had died due to a "seizure disorder ". He indicated that the death was related to sudep, "because everything else has been ruled out. " he did not believe that the vns caused or contributed to the pt's death.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
donnie welty, rn bsn
100 cyberonics blvd.
ste., 600
houston , TX 77058
(281) 228 -7200
Device Event Key847600
MDR Report Key861006
Event Key783108
Report Number1644487-2007-00767
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 05/07/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/06/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date07/31/2003
Device MODEL Number102
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received05/07/2007
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Type of Device Usage Initial

 
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