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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 01/01/2010
Event Type  Injury  
Event Description

It was reported that the patient was placed in an inpatient (b) (6) hospital and put on suicide watch due to increased depression. The relationship of the increase to pre-vns levels is unknown. It is also unknown if there is any relationship between the increased depression and vns, but the patient's treating physician wanted to increase her output current from 1. 0 ma to 1. 25 ma. Attempts for further information have been unsuccessful to date.

 
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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 Key1650535
Report Number1644487-2010-00790
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 03/02/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/01/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2011
Device MODEL Number103
Device LOT Number201083
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received03/02/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2009
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: 04/01/2010 Patient Sequence Number: 1
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