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

Model Number 303-30

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

Patient Problems Pain (1994); No Code Available (3191)

Event Date 03/31/2020

Event Type  Injury  

Event 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.

Manufacturer Narrative

B3.Event date - correction - inadvertently put wrong date on initial mdr submitted.

Event 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.

Event 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
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11266921
• MDR Text Key: 229869581
• Report Number: 1644487-2021-00131
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750122
• UDI-Public: 05425025750122
• 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
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 02/03/2021; 03/24/2021; 03/26/2021
• Supplement Dates FDA Received: 02/25/2021; 03/24/2021; 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR