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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 102

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CYBERONICS INC PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 08/04/2009
Event Type  Injury  
Event Description

It was reported that a vns pt experienced an increase in depression. Currently, the relationship of the increase in depression to vns therapy is unk as good faith attempts to obtain additional info have been unsuccessful to date. Moreover, it is known that both system and normal diagnostics were within normal limits at the time of the event.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1444500
Report Number1644487-2009-01744
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/04/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/18/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2007
Device MODEL Number102
Device LOT Number13755
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/04/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/18/2009 Patient Sequence Number: 1
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