MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

Device Problems Fracture (1260); Therapy Delivered to Incorrect Body Area (1508); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Discomfort (2330); Depression (2361); Neck Pain (2433); Shock from Patient Lead(s) (3162)

Event Date 02/28/2020

Event Type  malfunction  

Event Description

It was reported through clinic notes that the patient sent in that at the end of (b)(6) 2020 she felt a more depressed and her vagal stimulator was not working well.Vns diagnostics were okay after this increased depression.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Manufacturer Narrative

D4 expiration date and h4.Device manufacture date, corrected data: added expiration and manufacturing date.Information inadvertently omitted from initial report.

Event Description

It was reported by the patient that she was having very bad pain with stimulation that starts in the shoulder and travels up to her neck.The next day, the patient reported that she was not having the pain any longer because the device had stopped working.She indicated her depression had been getting increasingly worse.Three weeks later, the patient reported that at her follow-up visit, her device's magnet mode had been turned on in error by a physician.She also reported that high impedance was detected on her device no further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

Patient reported that the intensity of her vns was getting stronger and stronger to the point that it is made her head jerk with it.She also reports that she was having trouble swallowing.No further relevant information has been received to dat.E no known relevant surgical intervention has occurred to date.

Event Description

It was reported that the patient's generator was replaced due to battery depletion.Impedance was within normal limits post-operatively.No further relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11038075
• MDR Text Key: 222401024
• Report Number: 1644487-2020-01711
• Device Sequence Number: 1
• Product Code: MUZ
• 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: 11/27/2009
• Device Model Number: 302-20
• Device Lot Number: 200395
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 01/05/2021; 03/10/2021; 04/23/2021; 08/11/2021
• Supplement Dates FDA Received: 01/05/2021; 04/02/2021; 05/18/2021; 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR