MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK; GENERATOR

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Fatigue (1849); Headache (1880); Perforation (2001); Complaint, Ill-Defined (2331)

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.

• Brand Name: PULSE GEN MODEL UNK
• Type of Device: GENERATOR
• 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 Key: 3939274
• MDR Text Key: 18731544
• Report Number: 1644487-2014-01803
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other
• 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 Received: 07/16/2014
• 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 Received: 01/20/2014
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR