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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 02/03/2009
Event Type  Injury  
Event Description

Reporter indicated vns therapy was experiencing increased depression, and was given medication. The patient's pre-vns depression level is unknown. Good faith attempts to obtain additional 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 Key1336473
Report Number1644487-2009-00464
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/05/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2005
Device MODEL Number102
Device LOT Number10464
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/05/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2004
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: 03/06/2009 Patient Sequence Number: 1
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