MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problems Foreign Body Reaction (1868); Implant Pain (4561)

Event Date 03/07/2023

Event Type  Injury  

Event Description

It was reported that the patient had their generator and lead explanted due to an allergy with teflon and other materials.Suspect device has not been received by manufacturer to date.No other relevant information has been received to date.

Manufacturer Narrative

(b)(4) device evaluation is not necessary because the reported event has been determined as not related to vns therapy.Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

Information was later received from the patient's epileptologist stating that they were unable to note documentation of allergic reaction.The physician did note that the explant was to preclude serious injury, not for patient comfort.The patient's surgeon reported that the allergic reaction was located at the generator site.The reaction presented as redness and chest wall pain.The explant surgery was for patient comfort only.

Manufacturer Narrative

B5.Corrected event description, initial report: inadvertently left out information received from epileptologist.

• Brand Name: PULSE GEN MODEL 102
• 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: 16656704
• MDR Text Key: 312441792
• Report Number: 1644487-2023-00397
• Device Sequence Number: 1
• Product Code: LYJ
• 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
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/05/2015
• Device Model Number: 102
• Device Lot Number: 202797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2014
• 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: 42 YR
• Patient Sex: Male