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	Neuropathy (1983); Pain (1994); Perforation (2001)
Date of Event	06/13/2025
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 following implant, the extravascular (ev) lead experienced oversensing of artifacts when the patient was being transferred from the operating table to the hospital bed.It was noted that ring 1 impedances were fluctuating so the device was left with ventricular fibrillation (vf) detection on and therapies off.Post-implant check three hours later showed four non-sustained ventricular tachycardia episodes of noise with continued variable impedances, therefore only noise timeout was switched off.It was noted that the lead was placed inside a second tunneling during implant, as the first positioning on the left edge of the sternum showed the lead slowly moving in a lateral direction during breathing.The next day a chest x-ray was performed in which the lead was found to be in the pleura.The ev lead was explanted and replaced closer to the midline.Intermittent p-wave oversensing was observed with the replacement lead.The patient was checked the next day and noted a bit of pain around the incision site.The new ev lead remains in use.No further patient complications have been reported as a result of this event.
Event or Problem Description
It was reported that following implant, the extravascular (ev) lead experienced oversensing of artifacts when the patient was being transferred from the operating table to the hospital bed.It was noted that ring 1 impedances were fluctuating so the device was left with ventricular fibrillation (vf) detection on and therapies off.Post-implant check three hours later showed four non-sustained ventricular tachycardia episodes of noise with continued variable impedances.Therefore, only noise timeout was switched off.It was noted that the lead was placed inside a second tunneling during implant, as the first positioning on the left edge of the sternum showed the lead slowly moving in a lateral direction during breathing.The next day a chest x-ray was performed in which the lead was found to be in the pleura.The ev lead was explanted and replaced closer to the midline.Intermittent p-wave oversensing was observed with the replacement lead.The patient was checked the next day and noted a bit of pain around the incision site.The new ev lead remains in use.No further patient complications have been reported as a result of this event.Additional information received noted that the lead design was not suspected as a culprit for pleural placement.The lead was new and not suspected of failing.It was further reported that the patient was seen in clinic approximately two months post implant and all measurements were acceptable.The patient experienced continued sharp pain in the upper left and right chest that was worse upon inspiration.It was noted that the overall frequency of the pain was reducing and was likely due to irritation following the procedure or possibly nerve irritation/neuropathic pain.The patient was treated with a neuropathic modulator for the pain.It was also noted that the patient was not concerned or bother by the pain.
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: 22299389
• Report Number: 2182208-2025-02991
• Device Sequence Number: 9739845
• Product Code: NVY
• UDI-Device Identifier: 00763000369736
• UDI-Public: (01)00763000369736(17)270306(10)102406525
• 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): 09/11/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: EAZ101
• Device Catalogue Number: EAZ101
• Device Lot Number: 102406525
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 09/02/2025; 09/11/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 09/04/2025; 09/11/2025
• Date Device Manufactured: 03/06/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 18 YR
• Patient Sex: Male