MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 303

Model Number 303-20

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/20/2020

Event Type  malfunction  

Event Description

It was reported that the generator was returned due to an unknown reason.Product analysis (pa) for the generator was completed.There were no performance, or any other type of adverse conditions found with the pulse generator.The generator's internal data was reviewed and high impedance was seen.As the explant date is unknown, this high impedance cannot be attributed to the explant procedure with any certainty.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

This generator was received in a shipment of generators on (b)(6)2024 and was confirmed on (b)(6)2023 to be returned due to a standard generator replacement per the hospital (queen elizabeth hospital).This hospital has historically and currently reports any complaints or troubleshooting issues to livanova directly.Therefore if this generator was related to a true high impedance while implanted in a patient, they would have reported to us at that time they were aware.Due to privacy laws, the united kingdom cannot send implant or explant dates of the generators unless there is an active complaint alleged.Upon return this generator it showed high impedance in data history during product analysis.This will not be captured as a high impedance device malfunction as this is an expected function of the generator to record any impedance change of >25% which occurs both before implant and after explant due to not having lead connected while implanted in patient.Due to this and the information regarding all of these generators that were returned from this facility indicated to be explanted due to normal replacement, this high impedance is not indicative of a true malfunction and therefore will not be captured.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 303
• 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: 18946217
• MDR Text Key: 338205700
• Report Number: 1644487-2024-00323
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2019
• Device Model Number: 303-20
• Device Lot Number: 300347
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2015
• 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: 22 YR
• Patient Sex: Female