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

Model Number	398493
Medical Device Problem Codes	Failure to Sense (1559); Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Loop was explanted due to loss of sensing and noise.Patient reported a cardioversion on 29-sept-2023.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 reviewed and all production steps were performed accordingly.In particular, the final acceptance test proved the device functions to be as specified.The memory content of the device was inspected.The device data documented a loss of signal after (b)(6) 2023, thus confirming the clinical observation.In a next step the device was opened to inspect the inner assembly and to check the functionality of the electronic module.During the analysis, it was revealed that the electronic module was damaged.The damage symptoms clearly indicate a temporary high current, probably precipitated by the reported cardioversion.In general, the device is protected against the high voltage discharge during an external cardioversion, but depending on the position of the external cardioversion electrodes and individual patient circumstances a damage of the electronic module cannot be excluded.In conclusion, the analysis of the inner assembly of the device revealed that the electronic module was damaged due to a temporary high current, which was probably precipitated by the external cardioversion.There was no indication of a material or manufacturing problem.

• Brand Name: BIOMONITOR 2-AF
• 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: 18311568
• Report Number: 1028232-2023-06264
• Device Sequence Number: 15109762
• Product Code: MXD
• UDI-Device Identifier: 04035479135522
• UDI-Public: (01)04035479135522(17)200131
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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: 01/31/2020
• Device Model Number: 398493
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2019
• 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: 73 YR
• Patient Sex: Male