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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 08/09/2010
Event Type  Injury  
Event Description

A vns pt reported to the manufacturer that she was experiencing increased depression. The pt also stated that had lost over 150 lbs. In a year and a half time period, but the cause of the weight loss was not mentioned. The pt's physician stated that the pt was in the hospital but did not wish to provide any further info regarding the pt or reason for hospitalization.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1830847
Report Number1644487-2010-02035
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 08/09/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/08/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2007
Device MODEL Number102
Device LOT Number14277
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received08/09/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2005
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: 09/08/2010 Patient Sequence Number: 1
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