MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV CG FUTURE BAND; RING, ANNULOPLASTY

Model Number	638BL36
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	09/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that 2 years and 6 months post implant of this 36mm cg future annuloplasty heart band, at the patients year 2 follow-up, the patient developed atrial fibrillation (afib).Atrial fibrillation was not documented preoperatively, but the left atrium was noted to be massively dilated at baseline, which is often associated with atrial fibrillation.Medication was administered.The atrial fibrillation was possibly related to the valve, and a device-related adverse event could not be excluded.No laboratory tests or imaging were conducted.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.
Additional Manufacturer Narrative
B5: updated.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.
Event or Problem Description
Additional information was received that on september 3, 2025, the event resolved and the patient recovered.No additional adverse patient effects were reported.

• Brand Name: CG FUTURE BAND
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24406224
• Report Number: 9617601-2026-01358
• Device Sequence Number: 12837000
• Product Code: KRH
• UDI-Device Identifier: 00643169793637
• UDI-Public: (01)00643169793637(17)270515
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K052860
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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 Model Number: 638BL36
• Device Catalogue Number: 638BL36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/11/2026
• Date Device Manufactured: 05/16/2022
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 85 KG