MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Wound Dehiscence (1154); Chest Pain (1776); Unspecified Infection (1930); Seroma (2069)

Event Date 09/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient who was recently implanted has a golf ball sized lump over his generator.There is no redness or obvious signs of infection.The patient also reported that he had his device turned up recently and since that time he has had pain in his left chest and up into his left shoulder.The patient reported that the chest has become swollen like a golf ball.It is slightly warm to the touch, but not red.The patient saw the surgeon the surgeon decreased his output for the time being.It was also mentioned that the patient messed with the incision site which caused it to open a few centimeters and start to seep.The patient was advised not to bother the site and prescribed antibiotics.No additional relevant information has been received to date.

Event Description

Information was received indicating that the patient's lead came out of his neck incision.The physician's believe the patient has been picking at the site.It was indicated that the surgeon will be moving the patient's current vns system to his right side and checking lead integrity.The patient will also be placed on doxycycline for infection.Images were received that showed that the patient¿s lead is extruding out of his neck incision as well.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 6958245
• MDR Text Key: 89610584
• Report Number: 1644487-2017-04640
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/18/2019
• Device Model Number: 106
• Device Lot Number: 5183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2017
• 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; Required Intervention
• Patient Age: 31 YR