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

Model Number	102620-81A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is currently waiting for information regarding next removal attempt which is currently scheduled for (b)(6) 2024.The additional information will be provided in a supplemental report.
Event or Problem Description
On 30 september 2024, senseonics was made aware of an incident where physician was unable to remove the sensor sn (b)(6) on the first attempt made on 26 september 2024.
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".The insertion date of the sensor was (b)(6) 2024.As per the information that was provided to senseonics, the physician was unable to remove the sensor on the first attempt made on (b)(6) 2024.The sensor was successfully removed during the second removal attempt which took place on (b)(6) 2024.This incident does not require any further investigation.B4.Date of this report updated to 13 november 2024.D6b.Explanted date updated to (b)(6) 2024.G3 date received by the manufacturer ?07 november 2024.H3.Device evaluated by manufacturer? no.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: IMPLANTABLE GLUCOSE MONITORING SYSTEM
• 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: 20563263
• Report Number: 3009862700-2024-01005
• Device Sequence Number: 7817238
• 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
• Device Explanted 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): 11/13/2024

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/13/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Female