MAUDE Adverse Event Report: SENSEONICS INCORPORATED EVERSENSE SENSOR; CONTINUOUS GLUCOSE MONITOR, IMPLANT

Model Number 102096-67A

Device Problem Difficult to Remove (1528)

Patient Problem Discomfort (2330)

Event Date 11/09/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

On (b)(6) 2018 senseonics was made aware of an adverse event where the physician was unable to explant the eversense sensor.The user experienced mild discomfort and pain during the procedure and was asked to revisit the clinic for removal.

• Brand Name: EVERSENSE SENSOR
• Type of Device: CONTINUOUS GLUCOSE MONITOR, IMPLANT
• Manufacturer (Section D): SENSEONICS INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876
• Manufacturer (Section G): SENSEONICS INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876
• Manufacturer Contact: sachin thanawala ; 20451 seneca meadows parkway; germantown, MD 20876-7005 ; 3015561625
• MDR Report Key: 8096702
• MDR Text Key: 128106790
• Report Number: 3009862700-2018-00002
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021410
• UDI-Public: 00817491021410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/09/2018

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/08/2018
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP04043
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other