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

Model Number	DDMB1D4
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury

• 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: 50598476
• Report Number: 9614453-2026-03574
• Device Sequence Number: 13287873
• Product Code: LWS
• UDI-Device Identifier: 00763000059491
• UDI-Public: (01)00763000059491(17)250228
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 09/03/2026

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 Expiration Date: 02/28/2025
• Device Model Number: DDMB1D4
• Device Catalogue Number: DDMB1D4
• 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: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Date Device Manufactured: 08/28/2023
• 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: 6935M55 LEAD, 5076-45 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male