MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number FR995-23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 12/08/2004

Event Type  Injury  

Event Description

Medtronic received information that approximately two weeks post implant of this aortic bioprosthetic valve, a permanent pacemaker was implanted.The reason for the permanent pacemaker was not reported.No additional adverse patient effects were reported.

Manufacturer Narrative

The device remains implanted, therefore no product analysis can be performed.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.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.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 15494042
• MDR Text Key: 300700110
• Report Number: 2025587-2022-02654
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00681490265904
• UDI-Public: 00681490265904
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FR995-23
• Device Catalogue Number: FR995-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female