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	01/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
This device was explanted due to battery error message and eri.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
We received your event description for the above mentioned device.As of today, the device is not available 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 re-investigated 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 returned data were thoroughly inspected.However, the root cause of the clinical observation was not determinable based on the available information.It cannot be excluded that a temporary battery voltage drop resulted in the displayed message, as mentioned in the complaint description, to alert the user in a timely manner.The data documented that the current consumption of the device was normal and as expected and the sensing and detecting functionality was not compromised.In summary, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.Based on the information available for analysis, the definite root cause of the clinical observation was not determinable.For a root cause investigation an analysis of the device itself would be required.Should the device become available for analysis, this investigation 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
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 15595059
• Report Number: 1028232-2022-05256
• Device Sequence Number: 16678194
• Product Code: MXD
• UDI-Device Identifier: 04035479135522
• UDI-Public: (01)04035479135522(17)180930
• 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: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

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: 09/30/2018
• Device Model Number: 398493
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 76 YR
• Patient Sex: Male