MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING ANNULOPLSTY TRICUSP CONTOUR 3D 26MM; RING, ANNULOPLASTY

Model Number	690R26
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Non specific EKG/ECG Changes (1817); Tachycardia (2095)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: 638bl32, serial/lot #: (b)(4), ubd: 06-feb-2024, udi #: (b)(4), pma/510(k): k011395.Product analysis: the device remains implanted; therefore, no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Conduction disturbances are known potential adverse effects associated with any cardiac or thoracic procedure (open or catheter-based) and can be resolved with medical treatment or the implant of a permanent pacemaker (with the risk-benefit ratio in favor of implant of the structural heart product).A conduction disturbance does not indicate a device malfunction or potential manufacturing issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that 5 days following the implant of these annuloplasty products, a permanent pacemaker was implanted due to atrial fibrillation, atrial flutter and atrial tachycardia.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RING ANNULOPLSTY TRICUSP CONTOUR 3D 26MM
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8778000
• Report Number: 2025587-2019-02194
• Device Sequence Number: 1999856
• Product Code: KRH
• UDI-Device Identifier: 00643169121676
• UDI-Public: 00643169121676
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,Followup
• Report Date (Section B): 08/08/2019

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: 12/12/2023
• Device Model Number: 690R26
• Device Catalogue Number: 690R26
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/08/2019
• 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: 79 YR
• Patient Weight: 101