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MAUDE Adverse Event Report

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CYBERONICS, INC. NI PULSE GENERATOR   Back to Search Results
Event Date 01/01/2003
Event Type  Injury   Patient Outcome  Life Threatening;
Event Description

Reporter indicated that the pt had experienced a total of 13 seizures the year prior and that pt had only experienced a total of 5 seizures 3 years before, prior to being implanted with vns therapy system.

 
Manufacturer Narrative

Report is incomplete due to the anonymous nature of the reported event. The pt did not give their name at the time of the initial report.

 
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Brand NameNI
Type of DevicePULSE GENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
houston TX *
Manufacturer Contact
darlene garner, rac
100 cyberonics blvd.
suite 600
houston , TX 77058
(281) 228 -7200
Device Event Key540306
MDR Report Key550791
Event Key523265
Report Number1644487-2004-00932
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 09/23/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/22/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/23/2004
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? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/22/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
1,PULSE GENERATOR.
 
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