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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 04/01/2010
Event Type  Injury  
Event Description

It was reported that the pt was experiencing an increase in depressive symptoms since (b) (6) 2010. On that day, the pt's vns settings were increased to 0. 5 ma from 0. 25 ma and the pt was started on trazodone. The pt's vns has since been turned off and the pt was taken off trazodone. The reporter believes the problem is most likely due to the medication addition, but decided to turn the vns off and try to turn it back on when the pt's mood improves. Attempts for further info 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 Key1678644
Report Number1644487-2010-01116
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/09/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/07/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2011
Device MODEL Number102
Device LOT Number2318
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/09/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2009
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: 05/07/2010 Patient Sequence Number: 1
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