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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 06/01/2009
Event Type  Injury  
Event Description

It was reported to the manufacturer that the vns patient was experiencing an increase in depression. The patient's device settings were lowered due to tolerability issues and perception of erratic stimulation. The increase in depression was indicated to be due to loss of therapy from the lowering of device settings. It is unknown if the increase is above pre-vns baseline. There was no trauma or manipulation of the device that may have contributed to the reported 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 Key1431957
Report Number1644487-2009-01663
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/07/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2008
Device MODEL Number102
Device LOT Number015709
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/07/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2006
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: 08/06/2009 Patient Sequence Number: 1
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