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

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

Patient Problem Fibrosis (3167)

Event Date 07/17/2023

Event Type  Injury  

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

It was reported that patient is referred for full revision surgery due to lack of efficacy, scar tissue, and increased impedance.No high impedance has been noted in the extensively detailed clinic notes, therefore high impedance will not be coded.The scar tissue is assumed to be on the lead body.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Implant card was received indicating the patient had a prophylactic battery replacement.The explant facility has responded that they do not have the device in their system.The device is assumed to have been discarded.No other relevant information has been received to date.

• Brand Name: LEAD MODEL UNKNOWN
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17511516
• MDR Text Key: 321040231
• Report Number: 1644487-2023-01098
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR
• Patient Sex: Male