MAUDE Adverse Event Report: SIESTA MEDICAL, INC. ENCORE SYSTEM; INTRAORAL DEVICE FOR SNORING AND OBSTRUCTIVE SLEEP APNEA

Model Number FG0002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 10/13/2023

Event Type  Injury  

Event Description

Physician reported that the patient was implanted with the encore system about a year ago and had early drainage from the superior incision.This was treated with antibiotics.Recently a pimple-like structure ws noted at the superior incision.It was not cultured as an infection and is not painful.The patient was treated with antibiotics, however this did not clear the area of the incision.The patient is expected to have the system explanted in the next 2-3 weeks to ensure the incision heals and the patient can move forward with pacemaker implantation.

• Brand Name: ENCORE SYSTEM
• Type of Device: INTRAORAL DEVICE FOR SNORING AND OBSTRUCTIVE SLEEP APNEA
• Manufacturer (Section D): SIESTA MEDICAL, INC.; 101 church street; suite 3; los gatos CA 95030
• Manufacturer (Section G): SIESTA MEDICAL, INC.; 101 church street; suite 3; los gatos CA 95030
• Manufacturer Contact: michael kolber ; 101 church street; suite 3; los gatos, CA 95030
• MDR Report Key: 18116224
• MDR Text Key: 327878076
• Report Number: 3008792120-2023-00021
• Device Sequence Number: 1
• Product Code: ORY
• UDI-Device Identifier: 00862211000206
• UDI-Public: (01)00862211000206(17)24093(10)0946
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG0002
• Device Lot Number: 0946
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• 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): Required Intervention