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

Model Number	CMRM6133
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: dtma1qq crt-d, 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 3 days after implant, the cardiac resynchronization therapy defibrillator (crt-d) was removed from the pocket to drain a hematoma.The device was placed back in the pocket with a antibacterial absorbable envelope.The patient continued to have problems with the pocket.It was decided after a pocket evaluation that the device and leads would be removed to allow the pocket to heal.It was noted that the tissue in the pocket appeared to be discolored and possible infection.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: 9306932
• Report Number: 2182208-2019-02017
• Device Sequence Number: 2171882
• Product Code: FTL
• UDI-Device Identifier: 00763000101619
• UDI-Public: 00763000101619
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2019

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: 10/31/2019
• Device Model Number: CMRM6133
• Device Catalogue Number: CMRM6133
• Device Lot Number: R117678
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/11/2019
• 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: 65 YR