MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 300

Model Number 300-20

Device Problems Corroded (1131); Fracture (1260)

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

Event Date 07/14/2022

Event Type  malfunction  

Event Description

It was reported that patient had presented in clinic with high impedance.X-rays have been taken for the patient.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

High lead impedance was confirmed during a review of the tablet data for the generator.Patient's settings were noted to be adjusted, and stim has been allowed to be activated despite high impedance seen.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

It was reported that a full revision had occurred.The explanted products have not been received to date.No other relevant information has been received to date.

Manufacturer Narrative

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

Event Description

It was reported that the explanted generator and lead were received by the manufacturer and underwent product analysis.The lead successfully underwent analysis.The generator analysis has not been completed to date.The analysis of the leads revealed that the leads were corroded (likely due to natural wear).The fracture was able to be successfully identified, however the fracture mechanism was not identified.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 300
• 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: 15185234
• MDR Text Key: 301914209
• Report Number: 1644487-2022-00955
• Device Sequence Number: 1
• Product Code: MUZ
• 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: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2002
• Device Model Number: 300-20
• Device Lot Number: 39953C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2000
• 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: 73 YR
• Patient Sex: Female