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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-30
Event Date 01/01/2009
Event Type  Malfunction  
Event Description

It was reported by a patient implanted for depression that she was experiencing an increase in depression. When diagnostics were performed, the device registered high impedance. It is unknown which diagnostics were performed. All attempts for more information have been unsuccessful. The relationship between the increase in depression and vns therapy is currently unknown.

 
Manufacturer Narrative

Device failure is suspected.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste 600
houston , TX 77058
2812287200
MDR Report Key1363434
Report Number1644487-2009-00584
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 03/02/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/27/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2008
Device MODEL Number302-30
Device LOT Number1290
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/02/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2005
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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