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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL UNKNOWN

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CYBERONICS, INC. PULSE GEN MODEL UNKNOWN Back to Search Results
Event Date 07/01/2009
Event Type  Injury  
Event Description

It was initially reported that the patient was sent to a gastroenterologist for consult due to aspiration problems. The patient is pending an egd test and if there is a need for a g-tube or fundoplication surgery. The vns was not turned off by the neurologist completely but the settings were turned down and pt only gets 7 seconds of stimulation every "so often" (timing is unknown). The relationship of the therapy to the aspiration is unclear at this time. Good faith attempts to obtain additional information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL UNKNOWN
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd., ste. 600
houston , TX 77058
2812287200
MDR Report Key1464448
Report Number1644487-2009-01898
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/06/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/04/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/06/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 09/04/2009 Patient Sequence Number: 1
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