MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 7 VR-T DF4 PROMRI; ICD

Model Number	429536
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
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 behaviour, which led to the clinical observation.Based on the data available for analysis the root cause for that behaviour 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.
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 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 behaviour, which led to the clinical observation.Based on the data available for analysis the root cause for that behaviour 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 was 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.Upon receipt, the device was interrogated.The interrogation could be properly performed and revealed the mos1 battery status.Battery trend data showed an unexpected voltage drop that resulted in the observed activation of 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.In order to obtain further insights, the icd was opened and the inner assembly was inspected.The visual inspection showed no anomalies.Subsequently the current consumption of the electronic module was verified by direct measurement and proved to be as expected and consistent with the interrogated icd data.There was no indication of a malfunction of the electronic module.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 inspection of the inner assembly identified a damaged insulation, which led to an elevated internal self-depletion.In conclusion, the analysis revealed an elevated internal self-depletion within the battery.Based on the analysis all therapy functions of the icd were entirely available while the device was implanted and in service.
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.

• Brand Name: RIVACOR 7 VR-T DF4 PROMRI
• Common Device Name: ICD
• 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: 21240633
• Report Number: 1028232-2025-00425
• Device Sequence Number: 19742895
• Product Code: LWS
• UDI-Device Identifier: 04035479156817
• UDI-Public: (01)04035479156817(17)220331
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2025

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: 03/31/2022
• Device Model Number: 429536
• Device Catalogue Number: 429536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 03/10/2025; 07/30/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 03/10/2025; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2020
• 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: 78 YR
• Patient Sex: Male