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

Model Number	398493
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This device was explanted due to patient complaint of discomfort.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 re-investigated and all production steps were performed accordingly.In particular, 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, confirming the clinical observation.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 confirmed 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 battery manufacturing.The battery was subjected to a visual and an electrical inspection as well as a microcalorimetry analysis.The visual inspection of the battery did not reveal any external signs of damage.The measurement of the battery voltage confirmed a depleted battery and the microcalorimetry analysis showed a normal heat dissipation.In a next step, the battery was opened for destructive analysis.During analysis no internal electrical short was evident.However, the occurrence of a temporary short circuit that contributed to an increased internal self-depletion cannot be excluded.In summary, the root cause for the premature battery depletion could not be determined conclusively.

• 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: 16947179
• Report Number: 1028232-2023-02514
• Device Sequence Number: 2252484
• 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: 2019
• 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): 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 05/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2019
• 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: 56 YR
• Patient Sex: Unknown