MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG BIOMONITOR IIIM; IMPLANTABLE CARDIAC MONITOR

Model Number	450218
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Device explanted due to eri indication with unexpected battery behavior.No adverse patient events were reported.Should additional information be received, this file will be updated.
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.
Additional Manufacturer Narrative
The device was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were reviewed and all production steps were performed accordingly.In particular, the final acceptance test proved the device functions to be as specified.During initial device interrogation a warning message was triggered regarding the battery condition.The battery status was eri, which was detected on october 09, 2025.The memory content documented a normal and expected current consumption, however, an inconsistency between current consumption and battery voltage was noted.Therefore, the device was opened and subjected to further investigation.The visual inspection of the inner assembly showed no anomalies.The measurement of the battery voltage showed a depleted battery.In a next step, the battery was disconnected from the electronic module.Further thorough investigation of the electronic module did not show any anomalies.In particular the current consumption proved to be normal and expected.The battery was 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 manufacturing.The battery was subjected to an electrical inspection as well as a microcalorimetry analysis.The microcalorimetry analysis showed an elevated heat dissipation.In a next step, the battery was opened for destructive analysis.Inspection of the inner assembly revealed evidence of an internal short circuit, which led to an elevated internal self-depletion within the battery and therefore contributed to the clinical observation.In conclusion, an elevated internal self-depletion within the battery was found to be the root cause for the clinical observation.

• Brand Name: BIOMONITOR IIIM
• Common Device Name: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 25127619
• Report Number: 1028232-2026-02251
• Device Sequence Number: 10694431
• Product Code: MXD
• UDI-Device Identifier: 04035479169862
• UDI-Public: (01)04035479169862(17)240930
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K200444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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: 09/30/2024
• Device Model Number: 450218
• Device Catalogue Number: 450218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2023
• 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; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female