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

Model Number	407145
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An in-clinic follow-up on (b)(6) 2025 indicated 45 percent battery remaining, with a calculated eri of 4 years, 0 months.However, eri was detected on (b)(6) 2026.The patient underwent an mri on (b)(6), 2026.It is recommended to manage the device as eri.Device remains implanted.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
We received your event description for the device and would like to thank you for supporting our post-market surveillance.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The information you provided has been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.Should additional relevant information or the device itself become available, the investigation will be updated.
Additional Manufacturer Narrative
The device was explanted on (b)(6) 2026.The device is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.

• Brand Name: EDORA 8 DR-T
• 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 ; 8772459800
• MDR Report Key: 25444500
• Report Number: 1028232-2026-02782
• Device Sequence Number: 5815393
• Product Code: NVZ
• UDI-Device Identifier: 04035479147648
• UDI-Public: (01)04035479147648(17)190228
• 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: 2018
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

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: 02/28/2019
• Device Model Number: 407145
• Device Catalogue Number: 407145
• 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: 06/08/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2017
• 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 Age: 41 YR
• Patient Sex: Male