MAUDE Adverse Event Report: MEDTRONIC MEXICO CONTOUR 3D; RING, ANNULOPLASTY

Model Number	690R32
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bradycardia (1751); Non specific EKG/ECG Changes (1817); Tachycardia (2095)
Date of Event	08/30/2023
Type of Reportable Event	Serious Injury
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information that 9 years and 5 months post implant of this 29mm mitral bioprosthetic valve and 32mm tricuspid annuloplasty ring, a permanent pacemaker was implanted.The reason for the permanent pacemaker was reported as bradycardia/tachycardia syndrome.No additional adverse patient effects were reported.
Event or Problem Description
Medtronic received additional information which indicated that the patient also had sick sinus syndrome (sss).It was stated that the elective replacement indicator on the patients pre-existing implanted permanent pacemaker was activated and the patient was undergoing this procedure for a generator change.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that changed the event description and device relatedness of this previously reported event.There is no evidence to suggest the device caused or contributed to a death or serious injury.Updated a4 updated a5b updated b5 updated b7 updated h6 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: CONTOUR 3D
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 20471958
• Report Number: 9612164-2024-04756
• Device Sequence Number: 17980173
• Product Code: KRH
• UDI-Device Identifier: 00643169121706
• UDI-Public: 00643169121706
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K101212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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: 12/20/2017
• Device Model Number: 690R32
• Device Catalogue Number: 690R32
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 12/19/2024
• Date Device Manufactured: 01/22/2013
• 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; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Race: Black Or African American