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

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

Patient Problems Arrhythmia (1721); Bronchitis (1752)

Event Date 12/20/2017

Event Type  Injury  

Event Description

It was reported that a patient who had bronchitis did not tolerate vns stimulation well due to bradycardia occurring for the patient during stimulation on times.It was noticed during an eeg for the patient that the bradycardia occurred exactly every 3 and a half minutes which corresponded with the vns on time.It was advised to decrease the pulse width and frequency however it is not known if these changes were made.No additional relevant information has been received to date.

Event Description

This event was found to have been previously reported in manufacturing report # 1644487-2017-05093.The patient and device information was received confirming that the report in this file was a duplicate of the report.All further information regarding the events for the patient will be reported in manufacturing report # 1644487-2017-05093.

• Brand Name: PULSE GEN MODEL UNKNOWN
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 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: 7187658
• MDR Text Key: 97269195
• Report Number: 1644487-2018-00076
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 02/08/2018
• 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
• Patient Outcome(s): Other