MAUDE Adverse Event Report: MEDTRONIC, INC. AIGIS-R MEDIUM; MESH, SURGICAL, POLYMERIC

Model Number	CMRM6122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 694765 lead, implanted: (b)(6) 2014; 419388 lead, implanted: (b)(6) 2004; 4068-45 lead, implanted: (b)(6) 2001.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient experienced an infection, with pus coming from the pocket.The entire system was explanted and later replaced.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient experienced an infection, with pus coming from the pocket.The entire system was explanted, with antibiotic treatment provided.The system was later replaced.No further patient complications have been reported as a result of this event.

• Brand Name: AIGIS-R MEDIUM
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 8538007
• Report Number: 2182208-2019-00765
• Device Sequence Number: 2431687
• Product Code: FTL
• UDI-Device Identifier: 00763000101602
• UDI-Public: 00763000101602
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Model Number: CMRM6122
• Device Catalogue Number: CMRM6122
• Device Lot Number: R109782
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 05/10/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 95