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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 08/12/2014
Event Type  Injury  
Event Description

It was reported that the study patient experienced an increase in seizures, epigastric pain with hospitalization, loss of appetite, vomiting, diarrhea and nausea. An adverse event form was received indicating that the patient experienced vomiting, diarrhea and gastroenteritis. It was reported these events were not related to vns and have been resolved. No additional relevant information has been received to date.

 
Event Description

Further information was received which disregarded vomiting and diarrhea as individual adverse events. The reported gastroenteritis was not associated with congenital anomalies or birth defect, it did not result in a persistent or significant disability or incapacity and it was not associated with other serious or important medical events. The reported gastroenteritis was not a life threatening event and it did not result in death.

 
Manufacturer Narrative

Report source; corrected data: the previously submitted mdr inadvertently did not indicate "study" as a report source.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key4278678
Report Number1644487-2014-03143
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/28/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/26/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2014
Device MODEL Number103
Device LOT Number3504
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/02/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/17/2012
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: 11/26/2014 Patient Sequence Number: 1
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