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

Device Problem Insufficient Information (3190)

Patient Problems Rheumatoid Arthritis (1724); Bradycardia (1751)

Event Type  Injury  

Event Description

An article titled "vagus nerve stimulation inhibits cytokine production and attenuates disease severity in rheumatoid arthritis" was reviewed which included adverse event involving vns patient.It was reported that the patient presented bradycardia during the study.This adverse event was related to the implantation procedure.

• Brand Name: PULSE GEN MODEL UNKNOWN
• 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: 5917241
• MDR Text Key: 53570644
• Report Number: 1644487-2016-01964
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• 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?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/04/2016
• 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): Life Threatening