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

Model Number	407138
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Device explanted due to eri indication with unexpected battery behavior.No adverse patient events were reported.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
The returned 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.The pacemaker was successfully interrogated and the pacemakers memory content was analyzed confirming the clinical observation.The device switched to the eri battery status on february 6, 2025.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 in eri mode.The analyzed data show that the eri battery status was triggered by the programmed high current consumption program (rv: 6.0 v @ 0.4 ms, lv: 4.4 v @ 1.0 ms) and not due to a depleted battery.In conclusion, the device proved to be fully functional.The analysis revealed that the eri battery status was not declared by a premature battery depletion.Instead, a high output program led the device to switch into the battery status eri.There was no indication of a material or manufacturing problem.
Event or Problem Description
Device explanted due to eri indication with unexpected battery behavior.No adverse patient events were reported.Should additional information be received, this file 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 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 21351832
• Report Number: 1028232-2025-00700
• Device Sequence Number: 7835391
• Product Code: NKE
• UDI-Device Identifier: 04035479147570
• UDI-Public: (01)04035479147570(17)220228
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P070008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2025

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: 02/28/2022
• Device Model Number: 407138
• Device Catalogue Number: 407138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 02/14/2025; 04/29/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 02/14/2025; 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2020
• 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
• Patient Age: 88 YR
• Patient Sex: Male