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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 01/01/2008
Event Type  Malfunction  
Event Description

It was reported that the pt was experiencing an increase in depression. It is unknown whether it is above or below the pre-vns baseline. All attempts for further information 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 77058-2017
2812287200
MDR Report Key1213115
Report Number1644487-2008-02557
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 09/23/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/23/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device EXPIRATION Date09/30/2007
Device MODEL Number102
Device LOT Number014460
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received09/23/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2005
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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