MAUDE Adverse Event Report: TYRX, INC. AIGIS-R LARGE; 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	09/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 4968 lead (b)(6) 2011, 6947 lead implanted: (b)(6) 2011, 5076 lead implanted: (b)(6) 2011.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that one day after the implant procedure, the patient experienced uncontrolled pain and a hematoma at the device site.Initially, the patient was going to monitor the site and no antibiotics were prescribed, however due to continued bleeding, swelling, and ecchymosis that extended into the axilla, the pocket was re-opened for exploration, the hematoma was evacuated, and antibiotics were started for the infection.It was later reported the device, right atrial lead, and right ventricular lead were explanted due to the infection; the left ventricular lead was capped.The system was later replaced.The patient was a participant in the (b)(6) trial ((b)(6).) no further patient complications have been reported as a result of this event.

• Brand Name: AIGIS-R LARGE
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TYRX, INC.; 1 deer park dr.; suites g, e; monmouth jct NJ 08852
• MDR Report Key: 7464662
• Report Number: 3005619263-2018-00049
• Device Sequence Number: 13850943
• Product Code: FTL
• UDI-Device Identifier: 00643169468795
• UDI-Public: 00643169468795
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K130943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2018

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: Lay User/Patient
• Device Expiration Date: 09/30/2016
• Device Model Number: CMRM6133
• Device Catalogue Number: CMRM6133
• Device Lot Number: 16H18755
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2016
• Initial Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DTBB1D1 CRTD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 35 YR
• Patient Weight: 85