MAUDE Adverse Event Report: MEDTRONIC, INC. TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE; MESH, SURGICAL, POLYMERIC

Model Number	CMRM6122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Impaired Healing (2378)
Date of Event	06/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 5076-52 lead, implanted: (b)(6) 2019; 5076-45 lead, implanted: (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the skin in the area of the incision was not healing, with pus drainage and possible infection noted.The physician opted to explant the entire system before the patient became symptomatic.The physician commented that the pocket looked good with no signs of infection, and the issue seemed to be isolated to the incision area.The patient also reported infection.A replacement system was implanted a few days later.No further patient complications have been reported as a result of this event.

• Brand Name: TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 8800993
• Report Number: 2182208-2019-01298
• Device Sequence Number: 3027345
• Product Code: FTL
• UDI-Device Identifier: 00763000101602
• UDI-Public: 00763000101602
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K130943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2019

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: 05/31/2019
• Device Model Number: CMRM6122
• Device Catalogue Number: CMRM6122
• Device Lot Number: R111944
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/17/2019
• 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: 71 YR
• Patient Weight: 75