MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-30

Device Problems Corroded (1131); Fracture (1260)

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

Event Date 03/30/2023

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 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 initially reported that the patient was referred for an explant due to unknown reasons.The lead and generator were returned for analysis.Product analysis (pa) was approved for the returned lead.Visual analysis identified that the pin coil was broken at the end of the portion.As the end of the pin coil was broken, the appearance suggests that a stress-induced fracture occurred.Additionally, visual analysis identified that the ring coil had two broken strands near the end portion, that were pitted.Due to the condition of the strands the fracture mechanism could not be determined.One portion of the coil had two breaks and the coil ends were also pitted.Similarly, due to the condition of the coil ends, the fracture mechanism could not be determined.Another portion of the coil was also broken at both its ends.The appearance of one of the ends of the pin coil, suggested that a stress-induced fracture occurred.The other end was pitted, therefore, the fracture mechanism could not be determined.Continuity checks were performed on the returned portions of the lead, and other than the conditions and eroded openings mentioned above, no other discontinuities were identified during the continuity check.The condition of the returned lead portions are consistent with conditions that typically exist following an explant procedure.Commentary and evaluation on a portion of the lead assembly and electrode array section cannot be made as they were not returned for analysis.Generator product analysis was approved for the returned generator.The generator was explanted due to unknown reasons.Programmed parameters gave expected diagnostics with near end of service (neos = no) observed.The pulse generator was monitored for more than 24 hours and an electrical evaluation was performed.Visual analysis noted residue on the feed-thru assembly, though this is related to the manufacturing process of the component.There were no performance, or any other type of adverse conditions found with the pulse generator.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 16798723
• MDR Text Key: 313856302
• Report Number: 1644487-2023-00504
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750108
• UDI-Public: 05425025750108
• 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 Assistant
• Type of Report: Initial
• Report Date: 04/24/2023

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: 08/12/2006
• Device Model Number: 302-30
• Device Lot Number: 011114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2004
• 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: 28 YR
• Patient Sex: Male