MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Chest Pain (1776); Tissue Breakdown (2681); No Code Available (3191)

Event Date 10/17/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as the device extrusion is not related to the functionality or delivery of therapy of the device.

Event Description

The patient reported discomfort following vns implant.The patient reports that they could see the vns generator and lead coming out of their skin.They also stated that they can feel the device sliding and moving close to their armpit.No known surgical intervention has occurred to date for the generator or lead.No other relevant information has been received to date.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.

Event Description

The patients generator was explanted.Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8277830
• MDR Text Key: 134098152
• Report Number: 1644487-2019-00113
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

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: 09/19/2019
• Device Model Number: 1000
• Device Lot Number: 204261
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/02/2019
• Initial Date FDA Received: 01/25/2019
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2017
• 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
• Patient Age: 27 YR