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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 01/12/2009
Event Type  Injury  
Event Description

Reporter indicated a vns therapy pt is experiencing an increase in depression. The patient's pre-vns depression level is unknown. The patient was also experiencing some adverse events reported on medwatch number 1644487-2009-00274, and subsequently underwent vns generator replacement surgery. Good faith attempts to obtain additional information and the product for analysis 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 Key1310983
Report Number1644487-2009-00275
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 01/12/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/11/2009
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? No
Date Manufacturer Received01/12/2009
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: 02/11/2009 Patient Sequence Number: 1
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