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

Model Number	407145
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Device could not be interrogated.Patient reported getting an x-ray last week.Device remains implanted.No adverse patient events were reported.Should additional information be received, this file will be updated.
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.
Additional Manufacturer Narrative
The device was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as the returned device data.The returned device data were analyzed thoroughly.The analysis revealed that the pacemaker switched into the safety backup mode on april 19, 2026, as a result of the detection of invalid memory content.By design, the pacemaker performs self-checks and is equipped with the ability to detect and repair invalid memory content.However, in the case of multiple invalid memory areas, the device cannot correct the memory content and switches into the safety backup mode to ensure patient safety.While in this safety program, the pacemaker is capable to deliver anti-bradycardia therapies.Upon interrogation a device status error message appears to notify the user.The manufacturing process for this device was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process which may be related to the clinical observation.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.

• 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: 24941690
• Report Number: 1028232-2026-01947
• Device Sequence Number: 5623794
• Product Code: NVZ
• UDI-Device Identifier: 04035479147648
• UDI-Public: (01)04035479147648(17)240831
• 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: 2023
• 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): 04/22/2026

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: 08/31/2024
• 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: 04/20/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2023
• 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
• Patient Age: 64 YR
• Patient Sex: Male