MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IPERIA 7 DR-T DF-1 PROMRI; ICD

Model Number	392409
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Device was explanted due to eos.No adverse patient events were reported.Should additional information be received, this file will be update.
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 icd was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were reviewed.All production steps were performed accordingly.The final acceptance test proved the device functions to be as specified.Upon receipt, the device interrogation revealed the eos battery status which was activated on august 26, 2025.The data also indicated multiple instances of the icd detecting strong electromagnetic fields, consistent with mri scans.One of those instances was on august 26, 2025, where neither auto mri mode nor detection-off programming had been applied prior to the mri detection by the icd.The icd was subjected to an electrical analysis.The eos status was cleared with a technical programmer, and subsequent interrogation indicated the device status mos2 and a battery voltage of 2.91 v.The ability of the device to deliver therapies was then 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 and the charging time was as expected.The icd was opened and the inner assembly was inspected.Visually no deficiencies were observed.The current consumption of the icd was measured revealing no anomalies.All measured data was found to be normal and as expected.Based on the analysis results, the eos status most likely resulted from an mri scan without prior activation of the mri mode.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 drop of the supply voltage below the eos level, resulting in the observed eos battery status.Thorough analysis of the device did not reveal any indication of a device malfunction.

• Brand Name: IPERIA 7 DR-T DF-1 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: 22958758
• Report Number: 1028232-2025-04357
• Device Sequence Number: 18550945
• Product Code: MRM
• UDI-Device Identifier: 04035479128777
• UDI-Public: (01)04035479128777(17)200331
• 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: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,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: 03/31/2020
• Device Model Number: 392409
• Device Catalogue Number: 392409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2025
• Supplement Date Received by Manufacturer: 09/04/2025; 03/18/2026
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/04/2025; 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2018
• 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: 81 YR
• Patient Sex: Unknown