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

Model Number 304-20

Device Problems Fracture (1260); High impedance (1291)

Patient Problems Fibrosis (3167); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2022

Event Type  Injury  

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 had high impedance.Surgeon was not able to full revision due to difficulty attaching new leads to the nerve.It was noted that the reason for replacement was battery depletion.Suspect product has not been received by manufacturer to date.No additional known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

B5.Corrected description of event, initial report: inadvertently left out operative report details and report of fibrosis.F10.Corrected health effect clinical code, initial report: inadvertently left out e2313 code.

Event Description

It was later reported that during pre-op, the patient's impedance was within normal limits.High impedance was seen upon first interrogation following the surgeon saying she had cut the lead.The pin was visualized past the second connector block while troubleshooting and system diagnostics were performed after each troubleshooting attempt.Generator diagnostics, cleaning the lead end and generator off was performed but the surgeon had cut the lead.The cause of attachment difficulties was fibrosis around the nerve.The new generator was left in the patient was the lead was discarded.Operation reported noted that during dissection of the generator and lead, a microfracture in the plastic of the lead near the superficial skin surface was noted.The generator was replaced with a new sentiva 1000 generator however after multiple impedance checks and then troubleshooting, it was evident at the impedances were high and therefore the microfracture seen in the plastic tubing of the lead was causing an issue and therefore the entire lead and stimulator needed to be replaced.Two out of the 3 vagal nerve contacts were able to be dissected out very carefully and removed.Exposure of the nerve was significantly difficult due to extensive scar tissue which was completely surrounding the nerve and many different layers.Still attempt was made to improve as much scar tissue as possible and place new vagal nerve contacts, however given the inability to remove some of the scar tissue around the nerve the contacts were not able to be placed in a stable fashion.No other relevant information has been received to date.

Manufacturer Narrative

H1.Corrected type of reportable event, supplemental #1 report: inadvertently left out change from malfunction to serious injury.

Event Description

It was later reported that in an additional surgery the surgeon was unable to attach the anchor coil to the nerve during a revision.Surgeon was able to remove the old leads and anchor, but there was a lot of scar tissue.Surgeon was successful with attaching the positive and negative electrode, but there was not room for the anchor.

• 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: 14982796
• MDR Text Key: 302213237
• Report Number: 1644487-2022-00835
• 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
• Report Date: 10/31/2022

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: 08/10/2021
• Device Model Number: 304-20
• Device Lot Number: 204208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 07/11/2022
• Supplement Dates Manufacturer Received: 07/13/2022; 10/06/2022
• Supplement Dates FDA Received: 08/04/2022; 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2017
• 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: 65 YR
• Patient Sex: Male