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

Model Number	436066
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Loop was explanted due to no sensing.No adverse patient events were reported.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.In particular, the final acceptance test proved the device functions to be as specified.The available data were thoroughly inspected.The recorded secgs documented a loss of signal since august 09, 2024.The root cause of these observations was not determinable.However, it cannot be excluded that external influences such as strong electromagnetic fields, like an mri, contributed to the observation.During the further course of the analysis the device could be re-initialized successfully without any difficulties.Afterwards the device was working as specified.At a next step the device was subjected to an electrical analysis.A sensing test was performed and the device sensed the attached heart signals free of noise, proving the sensing functions to be as specified.The analysis revealed no indication of a device malfunction.

• 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: 24435247
• Report Number: 1028232-2026-00964
• Device Sequence Number: 13338085
• Product Code: MXD
• UDI-Device Identifier: 04035479158453
• UDI-Public: (01)04035479158453(17)231231
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K190548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: 12/31/2023
• Device Model Number: 436066
• Device Catalogue Number: 436066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male