MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ACTICOR 7 HF-T DF4 IS-1 PROMRI; CRT-D

Model Number	429523
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.The analysis is therefore based on the inspection of the returned data as well as the quality documents associated with the manufacture of this particular device.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.The final acceptance test proved the device functions to be as specified.The available data have been analyzed.The 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 patient¿s 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
(b)(6) 2025 device explanted on (b)(6) 2025.The device was not returned for analysis.The analysis is therefore based on the inspection of the returned data as well as the quality documents associated with the manufacture of this particular device.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.The final acceptance test proved the device functions to be as specified.The available data have been analyzed.The 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 patient¿s 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.
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
On (b)(6) 2025 device explanted (b)(6) 2025.The icd was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were reviewed and all production steps were performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.As a first step in the analysis, the device was interrogated.The interrogation could be properly performed and it revealed the eri battery status.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.A fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a normal and expected sensing and shock delivery.In particular, the specified energy level was reached.At a next step the memory content of the device was inspected.The data showed an inconsistency between the amount of charge taken from the battery and the battery voltage, which led to the automatic activation of the eri battery status.The data analysis confirmed an unexpectedly low battery voltage.Therefore, the device was opened and the inner assembly was inspected.The visual inspection of the inner assembly showed no anomalies.The overall current consumption of the electrical module was directly measured and proved to be normal and as expected.Analysis of the electronic module revealed no indication of a malfunction.Therefore, the battery was disconnected from the electronic module and 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 battery was subjected to a visual inspection which did not reveal any signs of damage.In a next step, the battery was opened for destructive analysis.The analysis identified a short circuit within the battery, which led to an increased internal self-depletion and, as a result, to the clinical observation.In conclusion, the analysis revealed an elevated internal self-depletion within the battery.

• Brand Name: ACTICOR 7 HF-T DF4 IS-1 PROMRI
• Common Device Name: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 22568654
• Report Number: 1028232-2025-03453
• Device Sequence Number: 13070826
• Product Code: NIK
• UDI-Device Identifier: 04035479156688
• UDI-Public: (01)04035479156688(17)221130
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/23/2026

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: 11/30/2022
• Device Model Number: 429523
• Device Catalogue Number: 429523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 07/23/2025; 08/06/2025; 03/18/2026
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 07/23/2025; 08/07/2025; 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2020
• 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: 79 YR
• Patient Sex: Male