MAUDE Adverse Event Report: Biotronik SE & Co. KG Eluna 8 DR-T ProMRI; Pacemaker

Model Number	394969
Medical Device Problem Codes	Premature Elective Replacement Indicator (1483); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This device was explanted (b)(6) 2026.Patient presented to the emergency department on (b)(6) 2026.Per follow-up data showing changed parameters, the mode switch onset criterion was changed, and the ra sensitivity was decreased.The programming count changed from 22 to 25.It was also reported the patient underwent an mri on (b)(6) 2026, however there is not evidence that the device was properly put into mri mode.This device reached eri on (b)(6) 2026.Upon interrogation on (b)(6) 2026 it was reported an error message appeared.Device was explanted due to eri.
Additional Manufacturer Narrative
Biotronik submits this report to comply with fda regulations 21 cfr parts 4 and 803.Biotronik 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 biotronik, or its employees that the device, biotronik, 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.Biotronik will submit a supplemental report if additional relevant information becomes known.

• Brand Name: Eluna 8 DR-T ProMRI
• Common Device Name: Pacemaker
• Manufacturer (Section D): Biotronik SE & Co. KG; woermannkehre 1; berlin 12359 ; GM 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; +1(877)245-9800
• MDR Report Key: 50203714
• Report Number: 1028232-2026-03730
• Device Sequence Number: 5521748
• Product Code: NVZ
• UDI-Device Identifier: 04035479131937
• UDI-Public: (01)04035479131937(17)150131
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: Health Professional
• Device Expiration Date: 01/31/2015
• Device Model Number: 394969
• Device Catalogue Number: 394969
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 12/10/2014
• 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: Required Intervention; Hospitalization
• Patient Sex: Female