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 Unspecified Infection (1930); Tissue Breakdown (2681)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

Event Description

It was reported by the surgeon that the patient had ulcerations around the generator pocket site and could visibly see the generator.Clinic notes received indicated that the patient had some slight bleeding at the incision site and this was slowly breaking down the skin to where the generator was visible.There was no fevers, chills, or purulent drainage.Additional information was later received that the incision had fully healed from the initial implant surgery.The surgeon indicated since the generator was exposed this was classified as an infection.It was indicated that the cause of the extrusion was patient picking at the site.Both the lead and generator were explanted and replaced.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 history record¿s for the generator was reviewed.The generator passed final quality and functional specifications prior to release.The device was sterilized prior to being released for distribution.No additional relevant information has been received to date.

Event Description

Clinic notes for the patient were received and reviewed.It was indicated that the patient¿s initial implant of vns, the patient was initially doing well but then started noticing some slight bleeding from the incision site.This slowly broke down his skin to the point where the generator was fully exposed.The patient then underwent removal of the generator and portion of the lead.A new lead/generator were placed in a new location; however the patient then developed an abscess at the site of generator where the previous infection was at.The patient then underwent removal of the lead/generator again.The incision completely healed but then the neck incision site opened and had drained some pus.The area was treated with local wound care and silver nitrate.It appeared as though the site was almost healed per the patient¿s brother, however during clinic it was noted that the neck incision reopened and there was a new area of hyper granulation tissue which was draining some scant amount of pus.The patient indicated they were feeling well and did not complain of any pain.It was indicated that the vns is also working for the patient.The area with hyper granulation tissue was treated with silver nitrate.The chest incision was indicated to have healed with no signs of hematoma or infection.

Event Description

Information was received that the physician noticed the patient¿s chest incision site was red and bulged out.The patient is scheduled for evaluation from the surgeon and an i&d.It was indicated that the patient has two incisions and clarification was obtained that the old incision in which an infection was found and previous implants were explanted is where the swelling and puffiness is located.The other incision is for the new products that were implanted in the patient and was stated those incisions look good.Surgical report for the patient was received and reviewed.Notes indicated that the patient was taken back to surgery where there was chest wall abscess on the left side near the lead.It was indicated that the open drainage site was washed out.There was an ulcerated piece with small skin bridge which was cut through.The abscess site was probed and the old lead was found.The lead portion left in from the previous surgery was able to be accessed and removed fully.It was indicated that the patient tolerated the procedure well without any issues.It was indicated that the surgeon felt the remaining portion of the lead that was removed was the cause of the redness and puffiness.

• 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: 9129829
• MDR Text Key: 160378274
• Report Number: 1644487-2019-01890
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/22/2021
• Device Model Number: 1000
• Device Lot Number: 6245
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/02/2019
• 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: 55 YR