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

Model Number	303-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Muscle Spasm(s) (1966)
Date of Event	10/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while shopping, a patient experienced severe, sharp chest pain that was described as coming and going for 15 minutes, until stimulation was inhibited with the patient magnet.The patient then went to the emergency room and spent four days inpatient due to painful stimulation.During this time, his generator was disabled, and his chest pain disappeared.Once this occurred, the patient had the device re-enabled at lower settings than his original settings.The patient did not complain of discomfort until several hours later, when the chest pain returned.It was noted the chest pain intensified with inspiration and lessened when the patient leaned forward.Chest and lateral x-rays were performed and a loop was noted in the t1/t2 region, which was likely in reference to strain relief loop.The patient left the hospital with his device disabled, no medication changes, and a referral to see a neurosurgeon for vns replacement, revision, or removal.The neurosurgeon who saw the patient opted for a lead revision, as he believed there was likely something wrong with the lead (such as a fracture), despite lead impedance testing within normal limits.No surgical intervention has occurred to date.No additional information has been received to date.
Event or Problem Description
The physician's office reported that at the time the patient was admitted to the hospital for the chest pain he was having muscle twitching on both shoulders due to stimulation as assessed by the physician.This was determined after the device was switched off and the patient reported feeling a difference in the spasms.When the patient was referred to the surgeon for evaluation of these issues, the surgeon decided a surgery was needed.No additional information has been received to date.
Event or Problem Description
It was reported he patient had a generator replacement.The generator was discarded.No additional information has been received to date.

• Brand Name: LEAD MODEL 303
• Common Device Name: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9265656
• Report Number: 1644487-2019-02117
• Device Sequence Number: 1951448
• Product Code: LYJ
• UDI-Device Identifier: 05425025750122
• UDI-Public: 05425025750122
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/03/2017
• Device Model Number: 303-30
• Device Lot Number: 3811
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 12/26/2019; 02/05/2020
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 01/20/2020; 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 37 YR