MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 8103; GENERATOR

Model Number 8103

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

Patient Problems Chest Pain (1776); Depression (2361); Suicidal Ideation (4429); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/14/2021

Event Type  Injury  

Event Description

It was reported that study patient experienced increased depression and suicidal ideation.It was reported to be mild in severity, not related to implant procedure, not related to stimulation, possibly related to device, and recovering/resolving outcome.No additional relevant information has been received to date.

Event Description

Patient continues to have pain and device migration.Patient is unhappy with his experienced with vns.No additional relevant information has been received to date.

Manufacturer Narrative

H1.Type of reportable event; corrected data; supplemental report #1 inadvertently forgot to update overall file reportability.

Manufacturer Narrative

B5.Describe event or problem; corrected data; information was received prior to the submission of supplemental mdr #2 f10.Adverse event problem - health effect clinical code; corrected data; information was received prior to the submission of supplemental mdr #2 f10 health effect, clinical code: code e2402 utilized; appropriate term ¿migration¿ is not available.(note that although migration is an available medical device problem code, in this report¿s context, the migration does not reflect a problem with the functionality or delivery of therapy of the device.Therefore, a device problem code does not adequately capture the patient¿s adverse event.).

Event Description

Additional information was received that the patient reported that the device had moved in his chest and was causing discomfort.He was referred for evaluation and was scheduled for revision but the patient cancelled it.This appears related to the patient's depression as he noted he is in physical and emotional distress regarding the device issue.No known surgical intervention has occurred to date.

Event Description

The patient had chest discomfort that was mild and possibly related to device.The event was not related to vns stimulation or implant procedure.Patient medication changed due to pain.Patient sleep meds were temporarily increased to help with worsened insomnia due to anxiety.Patient met with surgeon to discuss steps- but there was no indication surgery was planned.It was noted that the patient was in no immediate danger and the event was assessed not to be a serious adverse event.Later it was reported the patient was scheduled for chest pocket revision but then the patient later noted he no longer wants the device and wants it explanted as he is in physical and emotional distress regarding the device issue.No additional relevant information has been received to date.

Manufacturer Narrative

B5.Describe event; corrected data; supplemental mdr #3 inadvertently omitted details known prior to submission.

Event Description

Additional information was received that medication was added for the patient's depression.

Event Description

Information was received that the event of chest discomfort, increased suicidal ideation and worsening depression has resolved/recovered.No additional relevant information has been received to date.

Event Description

The patient's chest discomfort is possible related to the device.It was noted the patient met with surgery assistant about potential next steps (i.E.Meeting with surgeon), patient is in no immediate danger, inc sleep med for temporarily to help worsened insomnia due to anxiety.Patient had pocket revision surgery.

Event Description

Patient wants explant of device.No known surgical intervention has occurred to date.

Event Description

Patient reports that the device had migrated and he is upset that it has taken this long to get it removed.He reports that it is impossible to get any sleep now because a wire leading from the battery to their vagus nerve is now tight and any time he raises his left arm to head level it becomes even tighter causing generalized discomfort and much increased anxiety.He reported that he never got full feeling back in his face and neck like the patient noted that portions of his face and neck are still numb 17 months later.

Event Description

It was reported that the patient had their device explanted.Per the report, the entire vns system was removed.The reason was noted to be due to migration and other previously reported events.Products return attempts will not be made as the explant facility is listed as a no-return site.

• Brand Name: PULSE GEN MODEL 8103
• 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: 12682517
• MDR Text Key: 277945571
• Report Number: 1644487-2021-01466
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750504
• UDI-Public: 05425025750504
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/12/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/14/2023
• Device Model Number: 8103
• Device Lot Number: 6911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 10/20/2021; 11/15/2021; 11/21/2021; 12/07/2021; 01/14/2022; 02/11/2022; 02/11/2022; 02/11/2022; 02/11/2022; 02/11/2022
• Supplement Dates FDA Received: 11/12/2021; 11/15/2021; 11/21/2021; 12/07/2021; 02/08/2022; 03/08/2022; 05/24/2022; 09/01/2022; 01/25/2023; 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• 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: 60 YR
• Patient Sex: Male