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

Model Number 304-20

Device Problems Therapy Delivered to Incorrect Body Area (1508); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Post Operative Wound Infection (2446); Shock from Patient Lead(s) (3162)

Event Date 07/12/2023

Event Type  malfunction  

Event Description

The patient was having their generator explanted due to a burning sensation felt with vns stimulation and an allergic reaction.The patient had their generator explanted which was returned, however not received to date.During this procedure, it was found that the patient's lead tubing was compromised.The lead was left implanted.The physician then noted that the cause of the compromised lead was unknown.The cause of the allergic reaction was noted to be due to an infection and the cause of the painful stimulation was the abraded lead.The cause of the flushing was unknown per the physician, but is likely associated with the infection at the site the infection was later noted to have an unknown cause and was noted to be isolated to the chest region.Device history records were reviewed for the lead and generator.The device passed all functional specifications and quality tests and were sterilized prior to distribution.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.

Manufacturer Narrative

F10.Adverse event problem (refer to coding manual) - health effect - impact code: f1903 should not have been included as lead was not explanted.H6.Adverse event problem codes (refer to coding manual) - type of investigation - b20 should have been included.

Manufacturer Narrative

The following information should have been included: information was received from the patient that they believe the cause of the abraded lead insulation is due to trauma the patient received to the lead site before explant.Additionally, the patient reported that their device frequently went off and caused them pain before explant.No other relevant information has been received to date.

Event Description

It was reported that the patient had their lead explanted and their vns system replaced.The lead has been returned for analysis, however has not been received to date.No other relevant information has been received to date.

Manufacturer Narrative

Supplemental #3 b5.Explanted lead was received but has not yet under gone product analysis.No other relevant information has been received to date.D9.Yes.12/14/2023.H3.Yes, product code: 02.

Event Description

Product analysis was approved for the explanted lead.The reported abraded inner and outer tubing was confirmed.During the visual analysis of the lead, two abraded openings were observed on outer tubing.Further inspection found inner tubes to be abraded, however, the inner tube abrasions did not penetrate to coils.In addition, an abraded opening was also found on outer tubing; the inner tubes in this area did not appear abraded.Continuity checks of the returned lead portion were performed during the functional analysis, and no discontinuities were identified.Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17460171
• MDR Text Key: 320424188
• Report Number: 1644487-2023-01034
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/18/2020
• Device Model Number: 304-20
• Device Lot Number: 5064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2016
• 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: 42 YR
• Patient Sex: Male