MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

Model Number 304-20

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dysphagia/ Odynophagia (1815); Nerve Damage (1979); Depression (2361); Irritability (2421); Suicidal Ideation (4429); Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient experienced dysphagia, hypertonia, incision site pain/reaction, generator site pain, ear pain, neck pain.The events were found to be definitely related to device implant.The lead protrusion/pulling sensation was reported to be definitely related to the device implant.Patient felt the lead was taut between the generator and anchor on the vagus nerve.Generator would flip to the thin side with the patient laid down.Patient could correct this movement.The lead was reported to be protruding against the patient's neck.Patient was reported to have "played" with his generator cause the device to flip leading to the lead being taut in the neck.Lead revision was performed.No lead damage was observed; however, the lead was twisted in a tight coil close to the generator.Patient has continued the clinical trial uninterrupted.No additional relevant information has been received.

Event Description

It was received that the patient's suicidal ideations have resolved.No additional relevant information has been received.

Event Description

The clinical patient also experienced muscle spasms.A mild infection from initial implant was reported to have occurred and resolved.The dysphagia, hypertonia, incision site pain/reaction, generator site pain, ear pain, neck pain and muscle spasms were reported to have resolved.

Manufacturer Narrative

B5: describe event or problem: correction: muscle spasms was inadvertently not included on the initial mdr.

Event Description

Lead pulling sensation, incision reaction, dysphagia and device site pain has resolved and was noted to be definitely related to device/implant procedure.It was reported that following revision procedure patient has been experiencing suicidal ideation and depression.The events were noted to be related to implant procedure.No additional relevant information has been received.

Event Description

Information was received that patient was experiencing nerve injury with right neck sensation that make them feel as though they need to cough.The nerve injury is possibly related to device implant procedure, device, and stimulation.No additional relevant information has been received to date.

Manufacturer Narrative

B5.Describe event ¿ correction ¿ inadvertently updated related to device, stimulation and implant procedure was no included on supplemental mdr #4.

Event Description

Additional information was received that the nerve injury patient was experiencing has a relationship update to unlikely due to implant procedure and possibly related to stimulation and device.No additional relevant information has been received to date.

Event Description

Additional information was received that incision site pain and incision site reaction are no longer reportable events for the clinical trial.No additional relevant information has been received to date.

Event Description

Additional information was received that action was taken for nerve injury, depression, insomnia, and suicidality.The action taken is currently not specified.No additional relevant information has been received to date.

Manufacturer Narrative

B5.Describe event ¿ correction ¿ inadvertently did not include additional informiaton received on previous supplemental mdr.

Event Description

Additional information was received that the previously reported nerve injury was updated to dysesthesias and information regarding action taken for event was updated to no action taken.

Manufacturer Narrative

H1.Type of reportable event - correction - inadvertently did not indicate reportable event is malfunction on previous supplemental mdr.F10.Health effect - correction - inadvertently did not include e0623, e020202, and e0130 on previous supplemental mdr.F10 health effect, clinical code: code e2402 utilized; appropriate term ¿lead pulling sensation¿ is not available.Health effect - clinical code :e0130.Health effect - clinical code :e0623.

Event Description

Additional information was received that following lead revision that pain states they have been in constant pain and tightness in the chest.Since revision patient is having difficulty functioning.Neurologist found high impedance on generator and that when viewing x-rays which showed no obvious break or kinks in the electrode and it¿s in normal position.Patient went to neurosurgeon for further evaluation.Neurosurgeon is unsure why the patient is having this feeling in right side of the chest when implant is on the left but thinks the electrode may have been damaged back in december due to the kinking issue.Neurosurgeon recommended having stimulation turned off for about 4 weeks to see if symptoms go away no additional relevant information has been received to date.No surgical intervention for has occurred to date.

Event Description

Information was received that depression, insomnia and suicidality are no longer reportable within the clinical trial.There was no intervention reported to have taken place for the dysphagia.

Event Description

It was reported that the heart palpitations were no longer related to the device and still possibly related to stimulation and implant procedure.The event has still not recovered/not resolved.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• 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: 13079217
• MDR Text Key: 282727827
• Report Number: 1644487-2021-01833
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/30/2023
• Device Model Number: 304-20
• Device Lot Number: 205102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2019
• 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): Other; Required Intervention
• Patient Age: 47 YR