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

Model Number	429536
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent an mri on (b)(6) 2026, at approximately 12:45 pm pst.The device battery status indicated bos with a voltage of 3.12 v.On (b)(6) 2026, an alert was generated on hmsc for special device status and eri detection, with the battery voltage remaining at 3.12 v.Hmsc data confirms the last automatic mri mode activation occurred on (b)(6) 2026, at 12:45 pm pst, and an aborted shock was recorded in the vf zone during the mri.The patient was evaluated in clinic, where device reinitialization was performed.Device currently remains implanted.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
(b)(6) 2026 device was explanted (b)(6) 2026.
Additional Manufacturer Narrative
(b)(6) 2026 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.The inspection showed that the device was programmed to auto-mri on january 8th, 2026.An mri field was detected by the icd on the same day at 12:45 h, and the mri mode was activated, as expected.The data further documented that, on the same day at 12:44 h, noise detection led to two charging cycles, both of which were not delivered.The first shock was aborted due to reaching the maximum expected charging time, upon which eri was declared, as expected.The second shock was aborted by the mri field detection.After this event, the icd eri status was reset in the clinic and a manual capacitor reformation was subsequently performed.This led to a re-activation of the eri battery status due to reaching once more the maximum charging time.Based on the data available for analysis, it is reasonable to assume that the interrogation session on january 8th, 2026 at 12:33 h was not finished before the icd entered the mri scan, thus leading to noise detection and the documented charging cycles.This charging during the mri scan presumably led to a damage of the icd.If a charging cycle occurs in a strong external magnetic field, depending on strength and orientation, a saturation of the high voltage transformer may appear, leading to a temporary high current condition.This induced high current condition may possibly lead to damages of the electronic module.However, this can only be determined upon analysis of the icd itself.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.Should the device become available, this report 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
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 24047566
• Report Number: 1028232-2026-00156
• Device Sequence Number: 21198597
• Product Code: LWS
• UDI-Device Identifier: 04035479156817
• UDI-Public: (01)04035479156817(17)250831
• 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: 2025
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 01/26/2026

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: 08/31/2025
• Device Model Number: 429536
• Device Catalogue Number: 429536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 01/15/2026; 01/23/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 01/19/2026; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2023
• 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: 50 YR
• Patient Sex: Male