MAUDE Adverse Event Report: MEDTRONIC, INC. EPSILA EV¿; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	EAZ101
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Cardiac Perforation (2513)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during the implant of the extravascular (ev) lead, the sternal tunneling tool and sheathed lead were able to be advanced without issue, however the ev lead was observed to make windshield wiper movements and lacerated the pericardium.The lead and sheath were withdrawn, and some pneumopericardium developed due to suspected pericardial perforation.The incision was widened and the plane of the sternal tunneling tool was slightly raised, leaving it above the pericardium.The ev lead was fixed thrice in the new position, and air observed around the lead was removed from the pericardium with a vacuum drain.The fascia was then closed, and defibrillation threshold (dft) testing was then performed which initially was not successful at converting the induced rhythm; however, there was a subsequent delayed conversion to sinus rhythm.No additional dft testing was performed due to the suspicion of a negative influence from the pneumopericardium, and due to possible low sensing in the bipolar configuration.All therapies were turned off when the procedure was completed, and therapies were turned back on when the patient was discharged five days later.The ev lead remains in use.The patient is a participant in a clinical study.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Corrected: h6 annex a (pericardial perforation); h6 annex f (pericardial perforation); h6 annex g.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EPSILA EV¿
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635269277
• MDR Report Key: 19485971
• Report Number: 2182208-2024-02394
• Device Sequence Number: 8109837
• Product Code: NVY
• UDI-Device Identifier: 00763000369736
• UDI-Public: 00763000369736
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P220012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: Health Professional
• Device Expiration Date: 08/24/2025
• Device Model Number: EAZ101
• Device Catalogue Number: EAZ101
• Device Lot Number: 102423723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 04/21/2025
• Date Device Manufactured: 08/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 84 KG