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

Model Number	407137
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Hmsc reported eri detected on (b)(6) 2026.Battery reported as 35 percent on (b)(6) 2026.Nurse also reported battery was 2 years remaining during office follow-up in (b)(6) 2025.No current reported procedures.Device currently remains implanted.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
28-jan-2026 device explanted.The device was not returned for analysis.The analysis is therefore based on the returned 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 were analyzed thoroughly.The eri battery status was properly activated on january 16th, 2026 at 15:48 h.The data documents that the device was programmed with high output in the lv channel 6.5 v at 1.0 ms.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The analysis of the available device data showed no indication of a device malfunction.In particular, the eri battery status was anticipated.
Additional Manufacturer Narrative
The device was not returned for analysis.The analysis is therefore based on the returned 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 were analyzed thoroughly.The eri battery status was properly activated on january 16th, 2026 at 15:48 h.The data documents that the device was programmed with high output in the lv channel 6.5 v at 1.0 ms.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The analysis of the available device data showed no indication of a device malfunction.In particular, the eri battery status was anticipated.
Additional Manufacturer Narrative
(b)(6) 2026 device explanted.The pacemaker was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this pacemaker were reviewed and all production steps were performed accordingly.The final acceptance test proved the device functions to be as specified.Upon receipt, the pacemaker interrogation revealed the eri battery status since january 16, 2026.The data show that a high pacing output of 6.5 v at 1.0 ms was programmed for the left ventricle.This represents a high current program, which results in a faster battery discharge.The pacemaker was implanted for approximately 46 months.The amount of charge taken from the battery was verified.The battery condition was found to be normal and as expected.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.There was no indication of a device malfunction.In summary, the pacemaker was fully functional.The analysis did not reveal any sign of a material or manufacturing problem.In particular, the eri battery status was anticipated.

• Brand Name: EDORA 8 HF-T QP
• 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: 24115401
• Report Number: 1028232-2026-00315
• Device Sequence Number: 5941212
• Product Code: NKE
• UDI-Device Identifier: 04035479147563
• UDI-Public: (01)04035479147563(17)230531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P070008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/25/2026

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: 05/31/2023
• Device Model Number: 407137
• Device Catalogue Number: 407137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 01/22/2026; 01/28/2026; 03/25/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 01/22/2026; 01/29/2026; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• 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; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male