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); Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Device in backup mode.Unexpected battery behavior noted.No adverse patient events were reported.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
The device was explanted on (b)(6) 2025, due to eri.The device was not returned for analysis.The analysis is thus based on the inspection of the quality documents associated with the manufacture of this particular device as well as the data returned for evaluation.The manufacturing process for this device was reviewed and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the device functions to be as specified.The available data were thoroughly inspected.The data inspection revealed an unexpected battery voltage drop, which caused a corruption of the data, resulting in the reported backup mode.The last documented battery voltage was 1.5202fv, the lowest measurable value, indicating that the pacemaker can no longer provide therapy.Based on the data available for analysis the root cause for that behavior was not determinable and can only be clarified by an analysis of the device itself.However, it cannot be excluded that this occurrence resulted from a defective component.Should the device become available for analysis, this investigation will be updated.

• Brand Name: ELUNA 8 DR-T PROMRI
• Common Device Name: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 22993414
• Report Number: 1028232-2025-04404
• Device Sequence Number: 8997622
• Product Code: NVZ
• UDI-Device Identifier: 04035479131937
• UDI-Public: (01)04035479131937(17)180531
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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
• Device Expiration Date: 05/31/2018
• Device Model Number: 394969
• Device Catalogue Number: 394969
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2016
• 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: Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male