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	Pain (1994); No Code Available (3191)
Date of Event	03/31/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was initially reported that the patient was being referred for a prophylactic replacement.During follow-up with the patient, they reported to have fallen and felt their device had shifted as she now felt it near her throat and had to be careful swallowing food.Clinic notes for the patient were received indicating the patient fell on their right side and had pain at the vns site since then.At a later visit, the patient felt the vns had moved lower and more left than before due to the fall due to the fall.No known surgery has been reported to have occurred to date in relation to the events.No additional relevant information has been received to date.
Event or Problem Description
Response was received from the physician that there is no suspected migration present and that the pain is possibly related to just the presence of the device from the fall.The physician confirmed that the product was secured during initial implant.No additional relevant information has been received to date.
Additional Manufacturer Narrative
B3.Event date - correction - inadvertently put wrong date on initial mdr submitted.
Event or Problem Description
Additional information was received that prior to surgery, the patient reported that her device slid however the surgeon did not make a new pocket as there was no room for one, so he just placed the generator in the same location.The reason for replacement was noted to be prophylactic.No new additional relevant 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: 11266921
• Report Number: 1644487-2021-00131
• Device Sequence Number: 19658789
• Product Code: LYJ
• UDI-Device Identifier: 05425025750122
• UDI-Public: 05425025750122
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/20/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/07/2019
• Device Model Number: 303-30
• Device Lot Number: 4553
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 02/03/2021; 03/24/2021; 03/26/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 02/25/2021; 03/24/2021; 04/20/2021
• 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: Required Intervention
• Patient Age: 67 YR