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

Model Number	102620-81A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Event or Problem Description
Senseonics was made aware of an incident where user reported that physician was unable to locate or remove the eversense sensor during the removal procedure on (b)(6) 2025.Despite using tools such as a magnet and manual examination, the doctor could not find or feel the sensor.
Additional Manufacturer Narrative
Inability to remove the sensor is a known and anticipated potential adverse effect.User reported an unsuccessful removal attempt of the sensor sn (b)(6) on (b)(6) 2025.The sensor's site is the right upper arm.It was confirmed that an incision was made to attempt to remove the sensor.Despite using tools such as a magnet and manual examination, the doctor could not find or feel the sensor.As a result, the physician decided to leave the sensor implanted and closed the incision.The user wanted to know if it is safe to leave the sensor in place for extended period.User was advised that while the eversense sensor is intended to be removed at end of sensor life, it has undergone biocompatibility testing and meets the requirements of a permanent implant, and therefore it should not cause a biocompatibility concern if left in a patient.However eversense is not labeled as a permanent implant and that is not the intended use, so user would have to make arrangements to have the sensor removed.At the time of the call, the user was doing fine with no complications reported.No further information could be gathered due to lack of response from the user despite making multiple follow up attempts.B4.Date of this report 26 july 2025.G3.Date received by the manufacturer? 26 july 2025.H6.Type of investigation updated to 4111.H6.Investigation findings updated to 4248.H6.Investigation conclusions updated to 4311.

• 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: 22485162
• Report Number: 3009862700-2025-00936
• Device Sequence Number: 12772847
• Product Code: QHJ
• UDI-Device Identifier: 00817491022967
• UDI-Public: 00817491022967
• 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): 07/26/2025

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: 02/22/2025
• Device Model Number: 102620-81A
• Device Catalogue Number: FG-7201-00-301
• Device Lot Number: 01E183S
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 07/26/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2024
• 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: 68 YR
• Patient Sex: Female