MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-30

Device Problems Corroded (1131); Fracture (1260); High impedance (1291); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2022

Event Type  malfunction  

Event Description

It was reported that patient was seen to have high impedance.X-ray's are referred for the patient.X-ray's were reviewed by physician, and no determinations were made.No known relevant surgical intervention has occurred to date.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.

Event Description

It was reported that patient had both their lead and generator replaced due to the high impedance.No explanted products have been received to the manufacturer to date.No known relevant surgical intervention has occurred to date.

Event Description

It was reported that the explanted generator and lead are not available for return.No other relevant information has been received to date.

Manufacturer Narrative

D9.Device available for evaluation? corrected information; previous mdr inadvertently omitted information known prior to submission.B5.Describe event; corrected information; initial mdr inadvertently omitted information known prior to submission.

Event Description

The explanted generator and lead were in fact returned for product analysis, and have successfully undergone product analysis.During analysis of the generator, no anomalies were identified.During analysis of the leads, the end of one of the coil's was found to be broken.The broken end is dark, pitted and shows signs of metal dissolution.Due to the condition of the coil end, the fracture mechanism could not be ascertained.Continuity checks of the returned lead portions were performed during the functional analysis, and no other discontinuities were identified.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.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• 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: 15792170
• MDR Text Key: 307043735
• Report Number: 1644487-2022-01440
• Device Sequence Number: 1
• Product Code: LYJ
• 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: 03/31/2023

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: 12/22/2006
• Device Model Number: 302-30
• Device Lot Number: 11652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 01/04/2023; 02/10/2023; 03/06/2023
• Supplement Dates FDA Received: 02/01/2023; 02/13/2023; 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2004
• 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: 29 YR
• Patient Sex: Female