MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG BIOMONITOR 2-AF; IMPLANTABLE CARDIAC MONITOR

Model Number	398493
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.The analysis is thus based on the inspection of the quality documents associated with the manufacture of this particular device as well as the data returned for evaluation.The manufacturing process for this device was reviewed and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the device functions to be as specified.The analysis revealed an unexpected battery behavior, which led to the clinical observation.Based on the data available for analysis the root cause for that behavior was not determinable and can only be clarified by an analysis of the device itself.However, it cannot be excluded that this occurrence resulted from a defective component.Should the device become available for analysis, this investigation will be updated.
Event or Problem Description
This device was explanted due to eri with unexpected battery behavior.No adverse patient events were reported.Should additional information become available, 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 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, as mentioned in the complaint description.The battery status was eri, which was detected on (b)(6) 2024.The device data were thoroughly inspected.The analysis confirmed the activation of the eri battery status.The analysis showed a normal battery depletion.However, in situations with very low remaining battery capacity, a discrepancy between the remaining capacity calculated from the charge counter and the estimation based on battery voltage may occur.If this discrepancy exceeds the defined threshold, a battery error message is triggered 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.Next, the device was opened and subjected to further investigation.The visual inspection of the inner assembly showed no anomalies.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, revealing no anomalies.In conclusion, the analysis revealed no indication of a device malfunction.
Event or Problem Description
This device was explanted due to eri with unexpected battery behavior.No adverse patient events were reported.Should additional information become available, this file will be updated.

• Brand Name: BIOMONITOR 2-AF
• Common Device Name: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 20899252
• Report Number: 1028232-2024-06365
• Device Sequence Number: 20096926
• Product Code: MXD
• UDI-Device Identifier: 04035479135522
• UDI-Public: (01)04035479135522(17)170630
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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: 06/30/2017
• Device Model Number: 398493
• Device Catalogue Number: 398493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 84 YR
• Patient Sex: Unknown