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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 09/28/2014
Event Type  Injury  
Event Description

It was reported that the vns patient was experiencing nausea and pain at her electrode site during stimulation on-times. The patient was later diagnosed with gastroparesis and it was determined that her stomach was not producing enough gastric juices to promote digestion. Endoscopy and colonoscopy were performed and adjustments to the device settings were planned. Attempts for additional relevant information will be made.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4296768
Report Number1644487-2014-03204
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation PATIENT
Type of Report Initial
Report Date 11/04/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/04/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2014
Device MODEL Number103
Device LOT Number3495
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received11/04/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/10/2012
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: 12/04/2014 Patient Sequence Number: 1
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