MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 7 HF-T QP DF4 IS4 PROMRI; CRT-D

Model Number	429532
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Biotronik submits this report to comply with fda regulations 21 cfr parts 4 and 803.Biotronik has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by biotronik, or its employees that the device, biotronik, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Biotronik will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Patient had multiple shocks delivered on (b)(6) 2026 for arrythmias.When interrogated device had alert for eos.Device remains implanted.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
The icd 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 and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.The final acceptance test proved the icd functions to be as specified.The analysis showed that the eos battery status was activated due to a fast successive charging of many defibrillation shocks by the icd.In particular, a number of 40 charging cycles was performed by the device within 20 minutes on march 16, 2026, resulting in the eos activation.This indicates that the eos battery status was triggered due to this large amount of consecutive charging cycles and not due to a depleted battery.The data further shows that these charging cycles were caused by intrinsic heart signals.The data post eos reset shows normal battery voltage and normal charging time.There is neither an indication of an icd malfunction, nor an early battery depletion based on the data.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The analysis of the returned device data revealed no indication of a device malfunction.

• Brand Name: RIVACOR 7 HF-T QP DF4 IS4 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: 24629468
• Report Number: 1028232-2026-01349
• Device Sequence Number: 8852756
• Product Code: NIK
• UDI-Device Identifier: 04035479156770
• UDI-Public: (01)04035479156770(17)260228
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• 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): 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: 02/28/2026
• Device Model Number: 429532
• Device Catalogue Number: 429532
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2024
• 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: 67 YR
• Patient Sex: Unknown