MAUDE Adverse Event Report: Medtronic Europe Sarl Evera MRI XT DR SureScan; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	DDMB1D4
Medical Device Problem Codes	Signal Artifact/Noise (1036); Electromagnetic Interference (1194); High impedance (1291); Over-Sensing (1438); Low impedance (2285); Unstable Impedance (4085)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was undergoing neurological electrical stimulation therapy for cancer tumors in the lungs via a vest-like system delivering electrical stimulation over a twelve hour period.This system was interfering with the implanted implantable cardioverter defibrillator (icd), resulting in a spike and out-of-range low right atrial (ra) lead impedance with noise and oversensing observed.The right ventricular (rv) lead exhibited high, varying, and low out-of-range defibrillation impedance, as well a spike, out-of-range high, and out-of-range low rv pacing impedance values.It was reported that all lead alerts and trends were directly associated with the patient¿s use of the neurological stimulation system, and electromagnetic interference (emi) was identified as the cause of the out-of-range measurements and oversensing.Once the patient¿s physician elected to suspend the cancer treatment, impedance measurements appeared to remain stable with no additional oversensing observed.The device currently appears to be functioning as programmed.The icd remains in use.No patient complications have been reported as a result of this event.
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.

• Brand Name: Evera MRI XT DR SureScan
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): Medtronic Europe Sarl; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): Medtronic Europe Sarl; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(763)526-9277
• MDR Report Key: 50261982
• Report Number: 9614453-2026-03286
• Device Sequence Number: 10701400
• Product Code: LWS
• UDI-Device Identifier: 00763000059491
• UDI-Public: (01)00763000059491(17)240414
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/14/2024
• Device Model Number: DDMB1D4
• Device Catalogue Number: DDMB1D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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: 5076-52 LEAD, 6935M62 LEAD
• Patient Age: 56 YR
• Patient Sex: Male