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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 12/10/2017

Event Type  malfunction  

Event Description

A research article was received that compared seizure outcome from early (<= 5 years of age) and late (> 5 years of age) implantation of vns in children.This report captures one patient's increase in seizures after vns implant.Per the article data, this patient experienced an increase in seizure rate from 300 seizures per month to 450 seizures per month.In addition, one patient in the study experienced a postoperative infection, captured in mfr.Report # 1644487-2018-00164.No further relevant information has been received to date.

• 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: 7241144
• MDR Text Key: 99005501
• Report Number: 1644487-2018-00165
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/08/2018
• 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