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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 02/01/2010
Event Type  Malfunction  
Event Description

A vns patient called manufacturer and reported that they really needed to have their vns turned up. It was reported that their depression/anxiety has gotten so bad that they have quit their job and have so much panic that they don't leave home much. This has been occurring for the past few months. The depression was reported to have been so bad that she stays in bed 24/7 and can't cope. Follow-up was made with the patient's vns treating physician and the patient has not been into clinic to report the event.

 
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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 Key1638160
Report Number1644487-2010-00693
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 02/23/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/22/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2007
Device MODEL Number102
Device LOT Number014675
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received02/23/2010
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/01/2005
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: 03/22/2010 Patient Sequence Number: 1
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