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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK GENERATOR

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CYBERONICS PULSE GEN MODEL UNK GENERATOR Back to Search Results
Event Date 11/01/2013
Event Type  Injury  
Event Description

An article titled "perforated peptic ulcer in a child with a vagus nerve stimulator for seizure control" was reviewed. The article indicates that a (b)(6) year old male with a severe form of epilepsy presented with a perforated peptic ulcer. The patient presented to the emergency department with fatigue, decreased appetite, headaches and chest pain. There was no recent seizures activity, nausea, or vomiting. The patient subsequently underwent exploratory laparotomy, which demonstrated a perforation of the anterior aspect of the duodenal bulb. It was noted that the patient subsequently recovered and was treated with a proton pump inhibitor for acid suppression.

 
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Brand NamePULSE GEN MODEL UNK
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS
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 Key3939274
Report Number1644487-2014-01803
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Literature,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/20/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2014
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? No
Event Location Other
Date Manufacturer Received01/20/2014
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: 07/16/2014 Patient Sequence Number: 1
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