MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION RING TRI-AD 900SFC28; RING, ANNULOPLASTY

Model Number	900SFC28
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Bradycardia (1751); Non specific EKG/ECG Changes (1817)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 8 00sc26, serial/lot #: (b)(4), ubd: 30-sep-2021, udi#:(b)(4).Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that 7 days post implant of this mitral annuloplasty band and tricuspid annuloplasty ring, a permanent pacemaker was implanted due to tachy-brady syndrome, atrial fibrillation (afib), and atrial flutter.No additional adverse patient effects were reported. .

• Brand Name: RING TRI-AD 900SFC28
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8704807
• Report Number: 2025587-2019-01953
• Device Sequence Number: 16666908
• Product Code: KRH
• UDI-Device Identifier: 00643169195356
• UDI-Public: 00643169195356
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K093903
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2019

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: 12/31/2020
• Device Model Number: 900SFC28
• Device Catalogue Number: 900SFC28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 06/17/2019
• 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: 59 YR
• Patient Weight: 78