MAUDE Adverse Event Report: Medtronic Puerto Rico Villalba Epsila EV¿ MRI SureScan¿; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	EV240163
Medical Device Problem Code	Unstable Impedance (4085)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction

• 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--439 ; +1(763)526-9277
• MDR Report Key: 50875853
• Report Number: 2649622-2026-28233
• Device Sequence Number: 21188560
• Product Code: NVY
• UDI-Device Identifier: 00763000369781
• UDI-Public: (01)00763000369781(17)280715
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: EV240163
• Device Catalogue Number: EV240163
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 07/16/2026
• 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
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female