MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EDORA 8 DR-T; PACEMAKER

Model Number	407145
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.The analysis is therefore based on the received device data, as well as the inspection of the quality documents associated with the manufacture of this particular device.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.The final acceptance test proved the device functions to be as specified.The returned device data was analyzed thoroughly.The analysis revealed that the clinical observation resulted from invalid memory content.The battery is not depleted.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The clinical observation resulted from invalid memory content.The root cause for the invalid memory content was not determinable.However, external influences, such as strong electromagnetic fields, should be taken into consideration.
Event or Problem Description
This device shows eri with unexpected battery behavior.Device remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.

• Brand Name: EDORA 8 DR-T
• 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: 24829938
• Report Number: 1028232-2026-01657
• Device Sequence Number: 9187168
• Product Code: NVZ
• UDI-Device Identifier: 04035479147648
• UDI-Public: (01)04035479147648(17)240229
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: 02/29/2024
• Device Model Number: 407145
• Device Catalogue Number: 407145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2022
• 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
• Patient Age: 63 YR
• Patient Sex: Female