MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA EPSILA EV¿ MRI SURESCAN¿; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	EV240152
Medical Device Problem Codes	Decreased Sensitivity (2534); Device Dislodged or Dislocated (2923); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
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 next-day device check post-implant of the extravascular (ev) lead, a decline in r-wave measurements compared to implant was noted as well variations in sensing during respiration cycles.Pacing impedances were also noted to be slightly lower compared to at-implant values.X-ray imaging was performed which showed the ev lead had migrated.Reprogramming was performed to improve sensing, preemptively increase oversensing protection to maximum, and to obtain a new wavelet template.The physician was not concerned about the migration given final electrical measurements post-reprogramming, so the lead remains in use in the migrated position.No patient complications have been reported as a result of this event.

• Brand Name: EPSILA EV¿ MRI SURESCAN¿
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 25222183
• Report Number: 2649622-2026-14653
• Device Sequence Number: 21325441
• Product Code: NVY
• UDI-Device Identifier: 00763000369767
• UDI-Public: (01)00763000369767(17)270604
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P220012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: Lay User/Patient
• Device Model Number: EV240152
• Device Catalogue Number: EV240152
• 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: 04/24/2026
• Initial Report FDA Received Date: 05/19/2026
• Date Device Manufactured: 06/05/2025
• 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: DVEA3E4 EV-ICD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male