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 Ecchymosis (1818); Neck Pain (2433); Implant Pain (4561)

Event Date 03/22/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that patient felt muscle tightness around the area of their vns for several weeks.More recently patient has felt vns move from her collar bone more into her left breast.When palpating the tubing for the device could be felt and there is a large bruise on her left breast.The vns is firing every 2 minutes without a seizure being present and causing a lot of pain to patient.Her bruising has gotten bigger.Vns was disabled with magnet.The device is now moving around in patient¿s breast, the bruise around nipple has gotten bigger and the entire breast is sensitive to touch and motion along with being warm to touch.The shocks are occurring approximately every 2 minutes.They cause her to cough and choke every time they fire.The shock feeling goes all the way up her neck and around her shoulders.Some shocks are stronger than others.Patient has been taking ibuprofen - 400 to 600 mg alternating with tylenol.It will help with the muscle pain but will not alleviate it.Patient reports with ibuprofen her pain is a 3/10.No fevers, no concerns with patient¿s incisions, no discharge from her nipple and no drainage from incisions.Entire generator is palpable and easily able to be manipulated/moved.Per surgeon, vns generator does not appear to be functioning adequately.Recommended that patient continue to follow neurology's recommendation to leave vns off.Patient has been referred for surgical revision of incision.At time of surgery the generator had moved down into her breast tissue.Upon further evaluation, provider may have encountered a small amount of pus.Cultures were sent.She is not sure if it is pus or just drainage from the breast tissue.The area was thoroughly decorated along with the generator.The generator was re-anchored to a different pocket.The patient is being kept overnight and placed on iv antibiotics and will go home on keflex.No additional relevant information has been received to date.

Event Description

Additional information was received from provider indicating the reason for generator migration is due to no suture use to secure generator in pocket during initial implant and generator pocket infection.The surgery was for patient comfort and to treat infection.The cause of the bruising is due to the presence of the vns per the provider and due to the migration of the generator to the left breast.The cause of the infection and drainage found was noted to be related to presence of vns.At surgery vns generator was seen to have moved into the region of the left breast and is painful.Vns generator was in the left breast directly underlying the areola.When opened the pocket containing generator had cloudy fluid which has a slight odor.Bloodwork was sent at end of operation to evaluate for infection as a cause of the unexpected cloudy fluid in the vns generator pocket.Vns generator revision with repositioning of the existing m1000 into a new sq pocket just below the clavicle.Prior to repositioning the generator and the existing pocket in the region of the left breast was irrigated and debrided after finding purulent fluid in the pocket.Provider irrigated both pockets with copious amount of vancomycin solution.I then debrided the left breast pocket and cauterized the granulation tissue that was present.No additional relevant information has been received to date.

Manufacturer Narrative

H3.Device evaluated by manufacturer?, code 81, device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

Event Description

Additional information was received that patient¿s generator was explanted due to infection.No additional information has been received to date.

Event Description

Additional information was received that patient is having continuous drainage and there is id concern therefore remaining lead is now being explanted.

• 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: 14660379
• MDR Text Key: 294872128
• Report Number: 1644487-2022-00695
• 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
• Report Date: 01/05/2023

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: 02/18/2022
• Device Model Number: 1000
• Device Lot Number: 205213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 06/21/2022; 10/20/2022; 12/14/2022
• Supplement Dates FDA Received: 07/15/2022; 11/14/2022; 01/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2020
• 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): Other
• Patient Age: 17 YR
• Patient Sex: Female