MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem High impedance (1291)

Patient Problems Bradycardia (1751); Convulsion, Clonic (2222); Fibrosis (3167)

Event Date 06/29/2022

Event Type  malfunction  

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.

Event Description

It was reported that patient experienced a fall which resulted in a concussion.It is believed this fall may have contributed to the vns system high impedance.The patient has reported an increase in seizures recently.As well.An x-ray was performed on september 13th and has been reported ¿normal¿.The patient has been referred to the implanting center for a revision.The device history records of the lead were reviewed.The lead passed final quality and functional specifications prior to release.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

The patient underwent a full revision.During the revision surgery and prior to the actual replacement, it was discovered the explanted products have not been received to date.The patient later reported that they are having bradycardia in association with stim.Fibrosis was identified on the left vagus nerve.After follow up, it was discovered that the patient being reported prior is not the actual patient involved.This report will be used to update the patient information.No issue was reported for the patient previously captured in this report, no new record is needed to house original patient.No other relevant information has been received to date.

Manufacturer Narrative

D; suspect medical device; corrected information; patient product information not accurate upon initial submission.

Event Description

It was reported that the patient's lead showed no sign of fracture during the full revision.The explanted products have been received, but have not undergone product analysis to date.No other relevant information has been received to date.

Event Description

The explanted generator underwent product analysis in which the generator was found to be functioning as expected.During the explant procedure it was reported that fibrosis was visualized on the lead.This was not supplemental information previously as it was reported as the generator malfunctioning.However, with this report of fibrosis, this could be a potential cause of the high impedance seen.No other relevant information has been received to date.

Event Description

It was later discovered that the bradycardia seen around the time of replacement surgery was noted to occur after the replacement and therefore should not be included with the suspect product identified in this report.Mfr.Rep# 1644487-2023-00143 captures adverse events the patient experienced after replacement surgery on their newly replaced generator and therefore this report of bradycardia previously captured in this report will be moved to the aforementioned report.

Event Description

Additional tablet data was obtained and reviewed.No additional anomalies were identified during this review.New settings were included in this additional data.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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 15563975
• MDR Text Key: 301374118
• Report Number: 1644487-2022-01249
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/25/2019
• Device Model Number: 106
• Device Lot Number: 204278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 12/19/2022; 01/13/2023; 02/14/2023; 04/05/2023; 08/18/2023
• Supplement Dates FDA Received: 01/13/2023; 02/07/2023; 02/22/2023; 04/28/2023; 09/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/12/2019
• 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 Age: 15 YR
• Patient Sex: Male