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

Model Number 304-20

Device Problems Corroded (1131); Fracture (1260)

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

Event Date 05/15/2023

Event Type  malfunction  

Event Description

Hold for sh 6/9/23 it was reported patient underwent a full revision due to a lead fracture which was identified from an x-ray.X-rays have been requested for review but not received to date.Explanted lead has been requested for return but has not been received to date.It was noted that the explanted lead was "all kinked up".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

Product analysis was completed for the lead.The alleged lead fracture was confirmed during analysis.The lead ¿as received¿ had a knot in one area and was twisted in another area.In addition, during the visual analysis of the first portion, open abrasions, deep abrasions, and slanted abrasions were observed in various areas of lead body indicating the tubing had been twisted.These findings are consistent with patient manipulation/rotation of the device while it is implanted (twiddler).The ring coil break end appeared to have pitting on coil surface, and there appeared to be stress induced fractures likely caused by rotational forces.Though not conclusive, the broken ends of the returned portions are likely due to rotational forces caused by patient ¿twiddling¿ with device.The pin coil break end appeared pitted, had metal dissolution and electro-etching.Continuity checks of the returned lead portion was performed during the functional analysis, and no other discontinuities were identified.Other than the abrasions, fractures due to the twiddler condition, and pitting, no other anomalies were observed.No other relevant information has been received to date.

Manufacturer Narrative

H6.Investigation finding: c19 should not have been coded.H6.Investigation conclusions: d1101 should have been coded.

Event Description

Explanted lead received for product analysis.No other relevant information has been received to date.

• 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: 17097882
• MDR Text Key: 316860164
• Report Number: 1644487-2023-00728
• 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,Followup
• Report Date: 08/28/2023

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 Model Number: 304-20
• Device Lot Number: 7379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 06/13/2023; 08/28/2023; 08/28/2023
• Supplement Dates FDA Received: 07/06/2023; 08/28/2023; 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2022
• 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: 11 YR
• Patient Sex: Male