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

Model Number 304-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aspiration/Inhalation (1725); Paresis (1998)

Event Date 05/26/2022

Event Type  Injury  

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 patient occasionally aspirates, and have to time their swallowing with stimulation to avoid this.No additional or relevant information has been received to date.

Event Description

Per the physician the cause of the reported voice alteration, hypoesthesia, pain, and aspiration is unknown.

Manufacturer Narrative

B5.Describe event; corrected information ; initial mdr inadvertently omitted information known prior to submission f10.Adverse event problem; corrected information ; initial mdr inadvertently omitted information known prior to submission d4.Device information; corrected info; initial mdr inadvertently listed incorrect suspect product due to omitted information known prior to submission.

Event Description

It was reported that patient was experiencing voice alteration, pain (ear), painful stimulation (neck), hypoesthesia (left facial), aspiration, paresis, sleep disturbances, painful stimulation (ear), painful stimulation (jaw/tooth), pain (jaw/tooth).Patient was administered medication for the reported sleep disturbances, painful stimulation in the neck that they were experiencing and for fatigue.The device has been disabled.Due to the newly reported paresis, the implant procedure is likely the cause of the event.The other listed aes were exacerbated by the stimulation of the vns, but ultimately were likely caused by the vns surgery.No other relevant information has been received to date.

Event Description

It was reported by the patient that they are search for a new surgeon.The patient added that they continue to experience pain even with the device disabled and are in need of the explant immediately.Diagnostics are seen to be okay throughout.Physician identified an injury to glossopharyngeal nerve or recurrent laryngeal nerve.Still has pain along the jaw and neck.The painful episodes are less frequent but still with severe intensity.She still wakes up from pain sometimes.Patient is pursuing explant.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

It was reported that the patient's generator was explanted.The precise date of this explant is unknown.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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 15095343
• MDR Text Key: 296503474
• Report Number: 1644487-2022-00898
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 304-20
• Device Lot Number: 205624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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
• Patient Age: 61 YR
• Patient Sex: Female