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

Model Number	407137
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
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.
Additional Manufacturer Narrative
The device was explanted (b)(6) 2025.The device was not returned for analysis.The analysis is therefore only 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.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing.The final acceptance test proved the device functions to be as specified.In a next step, the returned device data was inspected.During the inspection the clinical observation could be confirmed.Analysis revealed an unexpected battery behavior, which led to the clinical observation.Based on the data available for analysis the root cause for that behavior was not determinable and can only be clarified by an analysis of the device itself.However, it cannot be excluded that this occurrence resulted from a defective component, which may compromise the ability of the device to deliver therapy.Biotronik has informed the health care professional about this analysis result, who decides, based on the patients individual circumstances and medical judgment, if the device will be exchanged.Should further relevant information or the device itself become available, this investigation will be updated and you will be informed accordingly.
Additional Manufacturer Narrative
The device was explanted (b)(6) 2025.The device was received and analyzed.Prior to the analysis of the device, the manufacturing process for this pacemaker was reviewed and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the device functions to be as specified.Upon receipt, the device was interrogated showing the eri battery status, which was triggered on (b)(6) 2025.The ability of the device to deliver therapies was tested.The anti-bradycardia pacing pulses in eri mode proved to be normal and in amplitude and frequency as programmed.There was no indication of a malfunction.In a next step, the pacemaker was opened and subjected to further analysis.The visual inspection of the inner assembly showed no anomalies.The current consumption of the electrical module was directly measured and proved to be normal and as expected.There was no indication of a malfunction of the electrical module.The battery was sent to the manufacturer for further analysis.The manufacturing records of the battery were inspected, documenting that the battery parameters were within specification during the battery manufacturing.No anomalies were documented during the production process associated with this battery.The visual inspection of the battery did not reveal any external signs of damage.Further extensive analysis of the battery, including destructive analysis, identified an elevated internal battery impedance, leading to the activation of the eri battery status.In conclusion, the therapeutic functionality of the device was tested and proved to be fully functional.Further investigations revealed an elevated battery impedance as the root cause of the eri activation.

• 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: 21894430
• Report Number: 1028232-2025-01974
• Device Sequence Number: 14335356
• Product Code: NKE
• UDI-Device Identifier: 04035479147563
• UDI-Public: (01)04035479147563(17)250630
• 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: 2024
• Device Explanted Year: 2025
• 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,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: 06/30/2025
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 04/29/2025; 01/14/2026
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 04/29/2025; 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female