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

Device Problem High impedance (1291)

Patient Problems Nausea (1970); Unspecified Respiratory Problem (4464)

Event Date 02/12/2016

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 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.(b)(4).

Event Description

It was reported that the patient had vns implant in 2016 and showed normal impedance during surgery.It was activated a month later, but then it had a high impedance.Stimulation was started, the stimulation parameters were gradually increased, which resulted in the appearance of stimulation side effects (nausea, hoarseness), so the stimulation intensity was reduced.Partial rupture of the electrode was suspected but not confirmed on x-ray examination.A slight improvement in the patients seizure frequency was noted during 6 years of stimulation.The device was discharged and the generator was replaced 6 years later.No damage was seen on the old generator that was uncovered, no fluid was present in the battery port and no abnormalities were seen macroscopically, the port screws were tight.The discharged device was removed and replaced with a new m106 device, intraoperative impedance was normal.No similar phenomenon had been encountered previously, and the device was released to the distributor with the intention of returning it to the manufacturer for testing.Explanted generator has not been received into product analysis to date.No other relevant information has been received to date.

Event Description

It was later reported that the explanted generator was received by manufacturer.Product analysis has not been completed to date.

Event Description

Product analysis was completed on the generator.The visual observations are most likely associated with manipulation of the device during the implant/explant procedures.An interrogation and a battery calculation were performed, which showed the generator's battery was completely depleted.The pulse generator was opened, the measured battery voltage confirmed a depleted battery condition.The device performed according to functional specifications.There were no performance, or any other type of adverse conditions found with the pulse generator.Internal generator data revealed the date of high impedance.

• Brand Name: LEAD MODEL UNKNOWN
• 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: 15905898
• MDR Text Key: 306597572
• Report Number: 1644487-2022-01549
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 03/09/2023; 04/26/2023
• Supplement Dates FDA Received: 04/03/2023; 05/19/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Other