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 Problem Unspecified Respiratory Problem (4464)

Event Date 01/24/2023

Event Type  Injury  

Manufacturer Narrative

Proposed second level coding - voice alteration to capture hoarseness or other vocal changes.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

It was reported that the patient is experiencing voice alterations.The patient's physician has referred the patient for a lead revision due to the voice alterations; the surgeon is also prepared to do a lead replacement, if necessary.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

It was reported that surgical intervention occurred to correct voice alteration, lead moved further down on the nerve.No devices were removed.No other relevant information has been received to date.

Event Description

It was reported that the patient notices the presence of the tie down after the lead revision.He believes that it is affecting his voice, pain (top of his larynx), and when turning his head for a long time it causes a spasm on his neck muscles (despite lead revision performed earlier).No other relevant information has been received to date.No relevant action has been taken to correct the adverse events (therefore will not be coded within this report as no serious injury has occurred with these new adverse events).

Event Description

X-rays were taken and sent to the manufacturer for review.The x-rays were provided after report of pain, muscle spasms, protrusion & voice alteration.The generator was not included in the field of view (fov).No commentary can be made on the placement of the generator nor any physical characteristics of the generator.The electrodes do appear to be further down the vagus nerve as previously reported.The visible portion of the lead was reviewed and assessed for breaks; none were detected.Stress relief bend was present; however, the strain relief loop was not.These are not placed per labelling.One or two adjacent tie-downs were present and placed per labeling as they are located after the strain relief bend.Based on the x-rays received, the cause of the pain, muscle spasms, protrusion & voice alteration is cannot be concluded based on the images provided, nor would any assessment be able to be provided as this is to be determined by a health care professional.Note that any fractures or microfractures on the portions of the lead that were not visible cannot be ruled out as well.No other relevant information has been received to date.

Event Description

It was later reported that the symptoms were continuing.The surgeon stated that the issue may be more neurological than mechanical.No other relevant information has been received to date.

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 16397744
• MDR Text Key: 309794393
• Report Number: 1644487-2023-00198
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/04/2023
• Device Model Number: 106
• Device Lot Number: 7067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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: 66 YR
• Patient Sex: Male