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MAUDE Adverse Event Report

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CYBERONICS, INC. PULSE GENERATOR   Back to Search Results
Model Number 102
Event Date 09/01/2007
Event Type  Injury   Patient Outcome  Other;
Event Description

It was reported that a patient became fixated on her vns and tried to "cut it out. " the md reported that he programmed the device off and the patient did get relief from her fixation with the vns. The md confirmed the patient had pre-vns psychiatric issues that were aggravated by the vns. The patient is being referred to a surgeon for explant.

 
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Brand NamePULSE GENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
michael carroll
100 cyberonics blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key901116
MDR Report Key927033
Event Key889196
Report Number1644487-2007-01600
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 09/19/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/15/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date11/30/2007
Device MODEL Number102
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received09/19/2007
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

 
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