MAUDE Adverse Event Report: Biotronik SE & Co. KG BIOMONITOR III; Implantable Cardiac Monitor

Model Number	436066
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury

• Brand Name: BIOMONITOR III
• Common Device Name: Implantable Cardiac Monitor
• Manufacturer (Section D): Biotronik SE & Co. KG; woermannkehre 1; berlin 12359 ; GM 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; +1(877)245-9800
• MDR Report Key: 50833648
• Report Number: 1028232-2026-04385
• Device Sequence Number: 16018009
• Product Code: MXD
• UDI-Device Identifier: 04035479158453
• UDI-Public: (01)04035479158453(17)240731
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K190548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 436066
• Device Catalogue Number: 436066
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/19/2026
• Date Device Manufactured: 01/27/2023
• 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; Required Intervention
• Patient Sex: Male