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 Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Device is at eri indication with unexpected battery behavior.No adverse patient events were reported.Device currently remains implanted.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
The device was explanted (b)(6) 2026.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.Therefore and in order to exclude any potential harm for the patient we would like to recommend to replace the device and to return it for analysis to biotronik.Of course, individual circumstances and medical judgment determine decisions about patient care and the frequency of follow-up sessions.The above recommendation is based on a purely technical assessment.Should further relevant information or the device itself become available this investigation 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 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.Therefore and in order to exclude any potential harm for the patient we would like to recommend to replace the device and to return it for analysis to biotronik.Of course, individual circumstances and medical judgment determine decisions about patient care and the frequency of follow-up sessions.The above recommendation is based on a purely technical assessment.Should further relevant information or the device itself become available this investigation will be updated.

• 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: 24429011
• Report Number: 1028232-2026-00948
• Device Sequence Number: 18703203
• Product Code: NIK
• UDI-Device Identifier: 04035479156770
• UDI-Public: (01)04035479156770(17)220930
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/09/2026

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: 09/30/2022
• Device Model Number: 429532
• Device Catalogue Number: 429532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 02/25/2026; 03/06/2026; Not provided
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 02/25/2026; 03/06/2026; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male