MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING TRI-AD 900SFC32; RING, ANNULOPLASTY

Model Number	900SFC32
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the return of the product, medtronic cannot make a definitive conclusion 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 during the implant of this annuloplasty ring, a permanent pacemaker was implanted.The reason for implant of a permanent pacemaker is unknown.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that the patient did not receive a permanent pacemaker during or post implant of this annuloplasty band and ring.The leads inserted at the end of the implant were for temporary pacing.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RING TRI-AD 900SFC32
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7514394
• Report Number: 2025587-2018-01134
• Device Sequence Number: 16500235
• Product Code: KRH
• UDI-Device Identifier: 00643169195370
• UDI-Public: 00643169195370
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K093903
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2018

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: 06/30/2020
• Device Model Number: 900SFC32
• Device Catalogue Number: 900SFC32
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/12/2018
• 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