MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Chest Pain (1776); No Code Available (3191)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr? device evaluation is not necessary as the migration and pain is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported via clinic notes for the patient's replacement surgery that the patient had a keloid scar at the generator site that occurred immediately with healing and at the time of revision, the keloid was resected and the scar looked "good" until (b)(6) 2020 (8-9 months after surgery) when an additional keloid developed.It was noted that also at this time, the generator migrated upwards in the chest wall and is now near the clavicle which is tender when palpated.The patient is able to tell the device is still functioning and remains seizure free.The patient is experiencing pain at the site of the device when laying on the left side to sleep and was seen to discuss repositioning surgery to anchor the muscle fascia to prevent the device from moving.The patient has occasionally occurring mild voice change with device suggesting that it is active.No additional relevant information has been received to date.No surgical intervention has occurred to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 11216592
• MDR Text Key: 228406976
• Report Number: 1644487-2021-00090
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2021

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
• Device Expiration Date: 05/21/2021
• Device Model Number: 106
• Device Lot Number: 204952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/03/2019
• 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: 44 YR