MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMUPLUS; RING, ANNULOPLASTY

Model Number	7700FB42
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Non specific EKG/ECG Changes (1817)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that 2 days post implant of this 42mm mitral annuloplasty ring, atrial fibrillation was observed on an electrocardiogram (ecg).It was stated that the patient was feeling well but had palpitations with atrial fibrillation overnight, therefore was placed on intravenous (iv) therapy with an antiarrhythmic medication.It was reported that the patients rate improved and their magnesium was replaced.It was noted that the patient was resumed on beta blockers and started on anticoagulant medication. the site assessed that the event is related to the device and to the implant procedure.It was reported that a follow-up electrocardiogram (ecg) performed one month later showed an atrial flutter.It was stated that the patient has a rate of 79 beats per minute (bpm) due to ongoing atrial fibrillation (afib) atrial flutter.4 days following the ecg, cardioversion was performed.An ecg performed 3 days following cardioversion showed sinus rhythm with premature ventricular contractions (pvc) and premature ventricular contractions (pac).No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SIMUPLUS
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19050027
• Report Number: 2025587-2024-02126
• Device Sequence Number: 12902931
• Product Code: KRH
• UDI-Device Identifier: 00763000271060
• UDI-Public: 00763000271060
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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: 01/05/2026
• Device Model Number: 7700FB42
• Device Catalogue Number: 7700FB42
• 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: 04/02/2024
• Initial Report FDA Received Date: 04/05/2024
• Date Device Manufactured: 01/14/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White