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

Model Number	398493
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Loop was explanted and reimplanted on (b)(6) 2017, approximately 10 days after implant.Loop had migrated around left breast implant of pt.Without any physical manipulation by patient.This caused significant physical discomfort to patient.On (b)(6) 2024 loop was explanted due to eri.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
Migration was observed following the implantation of this biotronik device.Therefore, the device as received was visually inspected.The visual inspection revealed no external anomalies.The memory content of the device was inspected, showing a normal device function while implanted and in service.The battery status showed 15%.The quality documents associated with the manufacture of this particular device were reviewed.There was no sign of any inconsistency during production and final acceptance test.In conclusion there was no indication of a material or manufacturing problem.
Event or Problem Description
Loop was explanted and reimplanted on (b)(6) 2017, approximately 10 days after implant.Loop had migrated around left breast implant of pt.Without any physical manipulation by patient.This caused significant physical discomfort to patient.On (b)(6) 2024, loop was explanted due to eri.Should additional information be received, 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: 19703224
• Report Number: 1028232-2024-03653
• Device Sequence Number: 17066345
• Product Code: MXD
• UDI-Device Identifier: 04035479135522
• UDI-Public: (01)04035479135522(17)170930
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: 09/30/2017
• Device Model Number: 398493
• Device Catalogue Number: 398493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 12/01/2025
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 36 YR
• Patient Sex: Female