MAUDE Adverse Event Report: ATRICURE, INC. ISOLATOR SYNERGY SURGICAL ABLATION SYSTEM

Model Number	EMR2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	09/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Case-(b)(4)- the device history record was reviewed for lot 118634 and contains no information that indicates devices were released with any non-conformance that would contribute to complaint.
Event or Problem Description
On (b)(6) 2023, a patient underwent a sinus node modification procedure.After the epicardial portion of the procedure, the patient's heart rhythm converted from sinus to junctional.Both the epicardial and endocardial portion of the procedure were completed, as planned.Post-operatively, the patient remained in junctional rhythm and was discharged from hospital without intervention on the third postoperative day.Junctional rhythm persisted along with symptoms related to chronotropic incompetence.The patient was admitted on (b)(6) 2023 for implantation of dual chamber pacemaker.There was no reported device malfunction, and the adverse event was the result of a procedural complication.
Additional Manufacturer Narrative
Udi related data quality updates only - correction to a previously submitted mdr for identified discrepancies between data submitted in mdr and data submitted to gudid.D4 - correction to unique identifier (udi) #.

• Brand Name: ISOLATOR SYNERGY SURGICAL ABLATION SYSTEM
• Common Device Name: ISOLATOR SYNERGY SURGICAL ABLATION SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 17933977
• Report Number: 3011706110-2023-00041
• Device Sequence Number: 20425133
• Product Code: OCL
• UDI-Device Identifier: 10840143902161
• UDI-Public: (01)10840143902161(17)250301(10)118634
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K110117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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: Health Professional
• Device Expiration Date: 03/01/2025
• Device Model Number: EMR2
• Device Catalogue Number: A000452
• Device Lot Number: 118634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PACEMAKER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Race: Black Or African American