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

Model Number	EAZ101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Pleural Effusion (2010)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id: dvea3e4 (serial: (b)(6)); product type: 0235-icd; implant date (b)(6) 2025.Product id: ev240163 ((b)(6)); product type: 0264-lead-hv; implant date: (b)(6) 2025.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 hours after implant, it was noted that the extravascular (ev) lead had dislodged into the pleura resulting in d iminished r-wave values and the chest x-ray showed pleural placement.The ev lead was turned off until the system can be revised.No further patient complications have been reported as a result of this event.
Event or Problem Description
It was further reported that the ev lead was explanted and replaced.It was indicated that the replacement ev lead was also possibly placed in the pleura as lead movement was noted with breathing; however, the replacement ev lead measurements were acceptable.Additionally, it was noted that the patient had a small pleural effusion around the left heart on chest x-ray.An x-ray performed a week after ev lead replacement showed the effusion was subsiding in comparison to how it was the previous week.The replacement ev lead remains in use.
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.
Additional Manufacturer Narrative
Correction: h6.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 55112-4391 ; 7635269277
• MDR Report Key: 23897555
• Report Number: 2182208-2025-13820
• Device Sequence Number: 14734777
• Product Code: NVY
• UDI-Device Identifier: 00763000369736
• UDI-Public: (01)00763000369736(17)260603(10)102415524
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P220012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/03/2026
• Device Model Number: EAZ101
• Device Catalogue Number: EAZ101
• Device Lot Number: 102415524
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 12/30/2025; 03/10/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 01/05/2026; 03/10/2026
• Date Device Manufactured: 02/26/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 80 YR
• Patient Sex: Male