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

Model Number 303-20

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

Patient Problems Neck Pain (2433); Choking (2464); Fibrosis (3167)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The doctor reported that the patient felt that her lead needed to be looked at or replaced.Patient stated that she felt that the generator was heavier on her chest and that she can feel scar tissue around the lead and felt that when she moved her neck, the lead pulled on her nerve.This pulling caused her to choke and cough which pulled the lead even more, causing her to vomit at times.Patient felt that there was no slack put into the lead.The patient also reported that her doctor recommended that she get vns generator that allowed her to have different settings at day and night since the stimulation at night does cause her to wake up at times due to autostimulation stimulating when she had increases in heart rates due to nightmares.Diagnostics were within normal limits.Clinic notes from the surgeon noted that the patient also had concerns about the wire being visible although he notes that the lead was "appropriately palpable".The lead pulling was noted to be painful.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

Per hospital policy, product return of the generator is not expected.

Event Description

It was reported that the patient & generator was replaced because the patient's autostimulation was keeping the patient awake at night.The explanted hasnt been received to date.No further relevant information has been received to date.

• Brand Name: LEAD MODEL 303
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11838911
• MDR Text Key: 251147283
• Report Number: 1644487-2021-00673
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/20/2019
• Device Model Number: 303-20
• Device Lot Number: 203682
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/17/2021
• Supplement Dates Manufacturer Received: 05/27/2021; 06/23/2021
• Supplement Dates FDA Received: 06/21/2021; 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR