MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR

Model Number	102812-81A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B4.Date of this report 07 june 2025.G3.Date received by the manufacturer? 07 june 2025.H6.Investigation findings updated to 4248.
Additional Manufacturer Narrative
Inability or difficulty to remove sensor during first attempt is a known and anticipated potential risk and eversense e3 user guide mentions about it under "risks and side effects".For this incident, the sensor could not be removed during the initial removal procedure which took place on (b)(6) 2024.The insertion date of the sensor was (b)(6) 2025.As per the information that was provided to senseonics, the sensor was unable to be palpated before the incision.Magnet was used to localize and removal attempt took an hour.Hcp was able to successfully remove the sensor on the second attempt made by a general surgeon on (b)(6) 2025.This incident does not require any further investigation.
Event or Problem Description
On (b)(6) 2025, senseonics was made aware of an incident where hcp was unable to remove the sensor on the first attempt made on (b)(6) 2025.However, the sensor was successfully removed during second removal attempt on (b)(6) 2025.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 22082184
• Report Number: 3009862700-2025-00648
• Device Sequence Number: 15459462
• Product Code: QHJ
• UDI-Device Identifier: 00817491022974
• UDI-Public: 00817491022974
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2025

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: Lay User/Patient
• Device Expiration Date: 05/02/2025
• Device Model Number: 102812-81A
• Device Catalogue Number: FG-7202-00-301
• Device Lot Number: 03E221S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 06/07/2025
• Initial Report FDA Received Date: 05/24/2025
• Supplement Report FDA Received Date: 06/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2024
• 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
• Patient Age: 67 YR
• Patient Sex: Male