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

Model Number 304-20

Device Problems Corroded (1131); Fracture (1260); Naturally Worn (2988)

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

Event Date 11/06/2022

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 reported that the patient was at an outpatient follow-up and presented with high lead impedance.The patient said that there was no known trauma to the implant site.Patient later had surgery due to high impedance.The products were explanted because the high lead impedance was not resolved despite multiple times of pin-reinsertion.During the surgery, the patient experienced bradycardia and cardiac arrest at the time of stimulation tests with new generator and lead.Therefore the new generator and lead were not implanted.The suspect product has not been received by manufacturer to date.No other relevant information has been received to date.This mdr houses the report of high impedance on the patient's old lead.Mfr ref #1644487-2022-01565 will house the report of bradycardia and cardiac arrest on the patient's new generator that was attempted to be used in surgery.

Event Description

It was later reported that the products were received.Product analysis has not been completed to date.No other relevant information has been received to date.

Event Description

Product analysis was completed on the returned lead.The lead assembly was returned for analysis due to fracture of lead.The allegation of fracture of lead(s) was confirmed.During the visual analysis of the second portion, the ring coil appeared to be broken.The broken ends of the coil appear dark and pitted; due to the condition of the coil ends the fracture mechanism cannot be ascertained.Continuity checks of the returned lead portions were performed during the functional analysis, and no other discontinuities were identified.The returned portions of the lead assembly have dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing, in some areas.No obvious point of entrance was noted other than the identified tube cut openings and the cut ends of the returned lead portions.Abrasions were observed in various areas, did not penetrate, likely due to wear.Four sets of set setscrew marks were observed on the connector pin.The marks provide evidence of a proper mechanical contact between conductive surfaces of both the generator and connector pin, thereby ensuring a good electrical connection to the lead at one point in time.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.Product analysis was also completed on the returned generator.The visual observations are most likely associated with manipulation of the device during the implant/explant procedures.An interrogation and a system diagnostic test were performed.The device output signal was monitored for more than 24-hrs and a comprehensive automated electrical evaluation 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 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: 15920775
• MDR Text Key: 307277966
• Report Number: 1644487-2022-01564
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• Combination Product (y/n): N
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2023

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: 02/08/2020
• Device Model Number: 304-20
• Device Lot Number: 203700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 12/15/2022; 01/12/2023
• Supplement Dates FDA Received: 01/05/2023; 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2016
• 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: 48 YR
• Patient Sex: Male