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 Erythema (1840); Implant Pain (4561)

Event Date 07/19/2021

Event Type  Injury  

Event Description

It was reported that a patient was experiencing pain and redness at the generator incision site.The events have been getting progressively worse.Patient was started on antibiotics and the redness has resolved.Patient is healing well.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.The device passed all functional specifications and quality tests and were sterilized prior to distribution.No additional relevant information has been received to date.

Event Description

The patient was treated with antibiotics and all adverse events subsided.No speculation for the cause of the events was provided by the provider.It was reported that the patient is still experiencing soreness at the wound site.Blood work showed no signs of infection.The patient's wound has closed.No additional relevant information has been received.

Manufacturer Narrative

G3.Date received by manufacturer - correction - 07/26/2021 should have been noted as the date received in the initial mdr.

Event Description

Patient was explanted due to infection.Lead and generator were explanted.The cause of the infection is unknown by physician.No additional relevant information has been received.

Event Description

Per the patient's father, pain pills were provided to the patient and the magnet taped over the generator for 3 days.There has been no change in the pain.Patient is scheduled for explant on 10/27 due to neck pains.

Manufacturer Narrative

B5.Describe event or problem - correction - additional information regarding the medication and neck pain not resolved was not included in the supplemental mdr #3 f10.Health effect - impact code - correction - code f2303 was not included in the supplemental #3 mdr.

Event Description

It was reported that the patient is experiencing redness and swelling at the vns generator site.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 12315240
• MDR Text Key: 266298417
• Report Number: 1644487-2021-01117
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/22/2022

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: 04/13/2022
• Device Model Number: 1000
• Device Lot Number: 205327
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 09/07/2021; 09/07/2021; 10/08/2021; 11/09/2021; 03/29/2022
• Supplement Dates FDA Received: 09/07/2021; 09/30/2021; 11/02/2021; 11/09/2021; 04/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/11/2020
• 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; Other
• Patient Age: 21 YR
• Patient Sex: Female