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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 12/01/2009
Event Type  Injury  
Event Description

It was reported that the pt was no longer feeling stimulation and was also having an increase in depression above pre-vns baseline. The pt's device was last checked in (b) (6) of 2009 and she is not currently seeing a physician who can check her vns as she recently moved. There have been no recent changes in the pt's lifestyle or medications, per reporter. 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 Key1637148
Report Number1644487-2010-00681
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 02/18/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/19/2010
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 Number13476
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received02/18/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2005
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: 03/19/2010 Patient Sequence Number: 1
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