MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION SIMPLICI-T BAND; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	670100
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	12/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that immediately post implant of this annuloplasty band, the band was explanted and replaced with an annuloplasty band of the same size and model.The reason for the replacement was not reported.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that one annuloplasty band was implanted in the mitral position and the other in the tricuspid position.Both bands remain implanted.Patient ethnicity and race updated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SIMPLICI-T BAND
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7233923
• Report Number: 2025587-2018-00266
• Device Sequence Number: 1476168
• Product Code: LWR
• UDI-Device Identifier: 00613994759276
• UDI-Public: 00613994759276
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2018

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: 04/18/2018
• Device Model Number: 670100
• Device Catalogue Number: 670100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 03/28/2018
• 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: 75 YR