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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103

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CYBERONICS INC PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 03/18/2010
Event Type  Injury  
Event Description

It was reported that a vns pt was in the emergency room. The pt had recently been reimplanted with another vns system and since that time it was reported that it hasn't really worked for him. The pt was having an increase in depression and suicide ideation and was hospitalized. They have since been discharged. It was felt that the events may be related to their stimulation. The pt has a history of suicide ideation pre-vns implant. It is unk if the pt's depression is over their pre-vns rate as their treating physician does not know their history pre-vns implantation, but felt it was an increase over their usual. The event did not occur after a medication change or programming change. No diagnostics have been performed at this time to check device function and will be performed when the pt returns to clinic.

 
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Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1678648
Report Number1644487-2010-01104
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/08/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/07/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2011
Device MODEL Number103
Device LOT Number2572
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/08/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2010
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: 05/07/2010 Patient Sequence Number: 1
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