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

Model Number 304-20

Device Problems Corroded (1131); Fracture (1260); Device Contamination with Body Fluid (2317); Naturally Worn (2988)

Patient Problems Convulsion, Clonic (2222); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2022

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 a patient scheduled for a battery replacement.Pre-op diagnostics showed high impedance and low output current.Generator was replaced and high impedance was still seen.Leads were then replaced and diagnostics showed good impedance.The suspect device has not been received by manufacturer to date.No other relevant information has been received to date.

Event Description

It was later reported that the generator and lead were received into product analysis.Analysis has not been completed to date.

Event Description

Product analysis (pa) for the generator was completed.The visual observations are most likely associated with manipulation of the device during the implant/explant procedures.An interrogation and system diagnostic tests were performed.The device output signal was monitored for more than 24-hrs and a comprehensive automated electrical evaluation was performed.No anomalies were seen, and the device performed according to functional specifications.There were no performance, or any other type of adverse conditions found with the pulse generator.Internal generator data revealed that the first date of high impedance was prior to day of surgery.Lead pa for was also completed.The lead assembly was returned for analysis due to lead fracture.The allegation of lead fracture was confirmed.During the visual analysis, the ring coil appeared to be broken.The coil break and break mate ends appeared dark and pitted and showed signs of metal dissolution.Due to the condition of the coil ends, the fracture mechanism could not be ascertained.Continuity checks of the returned lead portion was performed during the functional analysis, and no other discontinuities were identified in the returned portion.Dried body fluids were observed inside the inner and outer tubes in some areas.No obvious path of fluid ingress other than abraded openings possibly caused by wear and cut ends.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.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.

Event Description

It was later reported that the patient also had an increase in seizures due to the high impedance previously.

• 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: 16194730
• MDR Text Key: 307918104
• Report Number: 1644487-2023-00068
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/22/2023

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: 04/03/2023
• Device Model Number: 304-20
• Device Lot Number: 204871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 02/08/2023; 03/06/2023; 04/27/2023
• Supplement Dates FDA Received: 03/03/2023; 03/30/2023; 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2019
• 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
• Patient Age: 5 YR
• Patient Sex: Male