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

Model Number 304-20

Device Problem Material Twisted/Bent (2981)

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

Event Date 05/30/2023

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 livanovas 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 during a lead revision surgery, the surgeon intended to implant the patient with a m304-20 lead.This device had a kink in the middle electrode, so the patient was implanted with a different lead, m304-30.Suspect device has not been received by the manufacturer to date.No other relevant information has been received to date.

Manufacturer Narrative

Event Description

The patient's surgeon later elaborated on the link; in the middle electrode noting that it was too large for the patient and would not coil around the nerve properly.The suspect device was received by the manufacturer to undergo analysis.Analysis has not been completed to date.

Event Description

Product analysis (pa) was completed on the returned lead.The alleged damaged/ kinked coil was confirmed in the pa lab.During the visual analysis, a coil was observed to be kinked at 174mm, referenced from the tip of the connector pin.The kink likely occurred due to the manipulation of the lead during the implant/ explant procedures.Continuity checks of the returned lead assembly were performed during the functional analysis, and no discontinuities were identified.Overall length and resistance measurements of the complete returned lead were determined to be in compliance with those defined in the manufacturing specifications.The condition of the returned lead portion is consistent with conditions that typically exist following implant/explant procedures.The damage is likely related to the operational context.

• 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: 17190683
• MDR Text Key: 317786634
• Report Number: 1644487-2023-00810
• 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: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 304-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 39 YR
• Patient Sex: Male