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 Dyspnea (1816); Discomfort (2330); Implant Pain (4561)

Event Date 03/30/2023

Event Type  Injury  

Event Description

It was reported that the patient was experiencing painful stimulation in their neck, chest, and jaw; the stimulation was also causing the patient to experience a shortness of breath.The patient used their magnet to inhibit the stimulation, but reported still feeling the pain, just not as intense.An update was later received that the patient had their device disabled after the disablement, the patient noted that the pain subsided, diagnostics prior to the disablement were noted to be within normal limits.The physician ultimately referred the patient for an explant in order to better asses the events.The physician suspected that although diagnostics were ok, the lead appears to have eroded the patient's vagus nerve sheath and has come in direct contact with the nerve.Determination on the report of the vagus nerve eroding is not possible; however, this would also likely result in a lead impedance issue.Diagnostics were observed as ok and therefore not indicative of a malfunction.An implant card was received reporting the generator replacement.The reason for replacement was marked as 'other.' the patient followed up to have their replacement device turned on and denied any complaints.Product return attempts will not be made as the facility is listed as a no-return site.No other relevant information has been received to date.

Manufacturer Narrative

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.Health effect - clinical code :e2109.

Event Description

Response was received from the physician, that the explant was only done for patient comfort only.An update was later received adding that the patient continued to experience a painful shocking sensation in the neck, this time with their newly replaced generator.After lowering the patient's parameters, the patient still felt discomfort, and the physician decided to disable the device (diagnostics were observed ok).The patient was referred for a possible lead revision.Mfr.Report # 1644487-2023-00652 will house all further reports regarding the newly reported pain.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 16811306
• MDR Text Key: 313964652
• Report Number: 1644487-2023-00515
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 0105425025750061
• 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: 05/22/2023

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: 05/16/2022
• Device Model Number: 106
• Device Lot Number: 205363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• 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; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female