MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EDORA 8 HF-T; CRT-P

Model Number	407138
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When impedance testing was run at implant of the edora 8 hf-t fluctuations were seen resulting in <100ohm impedance measurements only when the device was programmed with vv delay 100ms / lv first.All psa testing was normal and vv delay of 80ms resulted in normal impedance results.Device remains implanted.Should additional information be received, this file will be updated.
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 on the returned device data.The manufacturing process for this device was reviewed.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.The final acceptance test proved the ipg functions to be as specified.The returned device data have been analyzed.Based on the data, there is no apparent leads problem.However, a defective pacemaker cannot be excluded.Despite, the data do not show any indication that therapy functionality may be affected.Please note, the currently available information is not sufficient for a detailed and conclusive analysis.In summary, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.Should further relevant information become available, this report will be updated.

• Brand Name: EDORA 8 HF-T
• Common Device Name: CRT-P
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 24037551
• Report Number: 1028232-2026-00127
• Device Sequence Number: 18394862
• Product Code: NKE
• UDI-Device Identifier: 04035479147570
• UDI-Public: (01)04035479147570(17)260831
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P070008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 01/14/2026

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
• Device Expiration Date: 08/31/2026
• Device Model Number: 407138
• Device Catalogue Number: 407138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2025
• 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: 76 YR
• Patient Sex: Male