MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Unspecified Infection (1930); Tissue Damage (2104); Tissue Breakdown (2681)

Event Date 11/09/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that this patient had to have their vns generator explanted due to an infection in the generator pocket.It was stated that the patient was hospitalized.A review of device history records showed that the implanted generator and lead were sterilized prior to distribution.All other quality tests also passed prior to distribution.No further 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

Postoperative notes were received which stated that the reason for surgery was due to an infected vagal nerve stimulator battery with wound dehiscence and moderate inflammation.There was complex wound debridement and drainage.Complex would repair greater than 7cm.Information was received that the patient presented in the emergency department (ed) with wound breakdown and exposed hardware and the ed doctor expressed purulence at the initial evaluation.There was no evidence of neck tenderness or infection at the neck wound site.It was determined to keep the lead implanted while just removing the generator.It was stated that there was some necrotic tissue and the tissue bed was debrided back to good healthy tissue.No further relevant information has been received to date.

Manufacturer Narrative

(b)(4).

• Brand Name: PULSE GEN MODEL 106
• 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: 8280839
• MDR Text Key: 134180200
• Report Number: 1644487-2019-00148
• 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,Followup,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/05/2019
• Device Model Number: 106
• Device Lot Number: 204281
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2017
• 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): Required Intervention
• Patient Age: 50 YR