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

Model Number	436066
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Device explanted due to unexpected drop in battery and upgrade to crt device.Should additional information be received this file will be updated.
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 re-investigated and all production steps were performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.The device was subjected to an electrical analysis, revealing that the device could not be interrogated with a programmer.Therefore, the device was opened and subjected to further investigation.A measurement of the battery voltage confirmed a depleted battery.The electronic module was connected to an external power source.The current consumption of the electronic module was found to be elevated.Further electrical investigations revealed that a low voltage capacitor of the electronic module was defective, which caused an increased current consumption and ultimately drained the battery.In conclusion, the clinical observation resulted from a defective low voltage capacitor on the electronic module.There was no sign of any inconsistency during the manufacturing process which may be related to the clinical observation.It is therefore assumed that the damage occurred after the device shipment, however the date of occurrence was not determinable.

• Brand Name: BIOMONITOR III
• 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: 24416819
• Report Number: 1028232-2026-00936
• Device Sequence Number: 14949285
• Product Code: MXD
• UDI-Device Identifier: 04035479158453
• UDI-Public: (01)04035479158453(17)230228
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K190548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 02/25/2026

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: 02/28/2023
• Device Model Number: 436066
• Device Catalogue Number: 436066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• 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: 37 YR
• Patient Sex: Female