MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 303

Model Number 303-20

Device Problems High impedance (1291); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Muscle Spasm(s) (1966); Seizures (2063); Neck Pain (2433)

Event Date 04/30/2019

Event Type  malfunction  

Event Description

It was reported that the patient is referred for replacement due to the vns causing severe shaking and the patient cannot tolerate it.The patient previously complained of painful stimulation in the neck and chest which appears to now be related to the reason for the patient's referral.She noted discomfort up the middle of the chest in which she uses the magnet to turn off the device.The patient reported she is bothered by her vns and feels that it is misfiring and going up her chest rather than on the side of her neck.She cannot tolerate the device being set at 1.0 ma or higher no known surgery has occurred to date.No additional information has been received to date.

Event Description

Product analysis for the lead was completed and approved.Note that since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.No anomalies were identified in the returned lead portion.Product analysis for the generator completed and approved.In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description

The lead and generator were received for analysis.Analysis is currently underway but has not been completed and approved to date.

Event Description

The patient underwent a full replacement.Data was received and reviewed for the patient's explanted devices.After review of the m105 decoder, it was found that the patient has had intermittent high impedance since (b)(6) 2019.Therefore, the patient¿s past reports of increase in seizures in (b)(6) 2020 previously reported in 1644487-2020-00109 and previous issues of painful stimulation, and muscle spasms (from (b)(6) 2019 continuing into 2020) were most likely all contributed from the patient¿s intermittent high lead impedance.From report #1644487-2020-00109: patient reported being in the emergency room due to 2 episodes during which the patient felt like she was having a seizure or stroke.The patient reported that she put the magnet over the generator and this stopped the event.Further information was received that the patient¿s device was disabled.A ct scan was performed and no stroke was observed on the scan.The emergency room doctor reported that he felt the cause of the event was the device.It was further noted that the patient does not have epilepsy or seizures.The explanted devices have not been received for analysis to date.

Event Description

Additional information received from the patient noting that she had a cap on her tooth in the past and was experiencing a shocking feeling because the vns was higher in her body and she believed the cap was interacting with the vns.As the patient was convinced this was the cause of her pain she asked her dentist to remove the cap and once removed she claims the pain went away.

• Brand Name: LEAD MODEL 303
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9723056
• MDR Text Key: 180724446
• Report Number: 1644487-2020-00283
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/02/2021

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
• Device Expiration Date: 05/08/2018
• Device Model Number: 303-20
• Device Lot Number: 3943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Event Location: Other
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/18/2020
• Supplement Dates Manufacturer Received: 02/27/2020; 03/24/2020; 04/21/2020; 08/09/2021
• Supplement Dates FDA Received: 03/23/2020; 04/16/2020; 04/30/2020; 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR