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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  Malfunction  
Event Description

It was reported to the manufacturer that the vns patient has been experiencing an increase in depression. It is unknown if the increase is above pre-vns baseline. The relationship between the increase and vns therapy is unknown. It was indicated that the patient's device settings will be modified to increase therapy for improved efficacy. Good faith attempts to obtain additional information have been unsuccessful to date.

 
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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 Key1492058
Report Number1644487-2009-01788
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/24/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/21/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number102
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/24/2009
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
Type of Device Usage Initial

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