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

Model Number	436066
Medical Device Problem Codes	Peeled/Delaminated (1454); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Fractal coating/silicone casing delaminated and fell apart upon explant, requiring clinician to dig pieces of the coating out of the patient.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
27-jan-2026 opened in error.Upon further examination it was determined that the fractal coating/silicone in question was actually scar tissue that had formed around the device in the pocket.All fractal coating/silicone around the device remained intact and did not separate from the device during explant.Closing report.

• Brand Name: BIOMONITOR III
• 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: 24188755
• Report Number: 1028232-2026-00448
• Device Sequence Number: 13224232
• Product Code: MXD
• UDI-Device Identifier: 04035479158453
• UDI-Public: (01)04035479158453(17)220430
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 436066
• Device Catalogue Number: 436066
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 01/27/2026
• Date Device Manufactured: 10/04/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female