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

Model Number 302-20

Device Problems Fracture (1260); Device Contamination with Body Fluid (2317); Naturally Worn (2988)

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

Event Date 07/08/2023

Event Type  malfunction  

Event Description

The patient underwent a full revision due to having a damaged lead.The suspect device was received and product analysis is underway.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 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

Product analysis was completed on the returned lead and generator.Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.The lead fracture allegation was not confirmed in the pa lab.Continuity checks of the returned lead portion were performed during the functional analysis, and no discontinuities were identified.Other than the abraded openings, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.Abrasions observed in various locations, possibly caused by wear.The lead assembly has dried remnants of what appear to have once been body fluids inside the outer and inner silicone tubes, in some areas; no obvious path of fluid ingress was noted other than the identified abraded openings and cut end.Generator analysis was completed and approved.An interrogation and system diagnostic tests were performed.The device output signal was monitored for more than 24-hrs and a comprehensive automated electrical evaluation (shows an ifi (intensified follow-up indicator)=no condition) was performed.No anomalies were seen, and the device performed according to functional specifications.There were no performance, or any other type of adverse conditions found with the pulse generator.

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18515004
• MDR Text Key: 333025850
• Report Number: 1644487-2024-00047
• 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
• Report Date: 03/13/2024

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: 10/02/2004
• Device Model Number: 302-20
• Device Lot Number: 7150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/15/2024
• Supplement Dates Manufacturer Received: 01/17/2024; 02/27/2024
• Supplement Dates FDA Received: 02/09/2024; 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2002
• 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: 46 YR
• Patient Sex: Female