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 Codes	Wound Dehiscence (1154); Erosion (1750); Unspecified Infection (1930)
Date of Event	01/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: dtba1qq crt-d, implanted: (b)(6) 2015.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
It was reported that the patient experienced erosion with wound dehiscence due to a suspected infection.The cardiac resynchronization therapy defibrillator (crt-d) system was extracted.A debridement of the site was performed and a wound vac was placed.The system was later replaced after the infection resolved.The patient is a participant in the (b)(6) study.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: 6876775
• Report Number: 3005619263-2017-00047
• Device Sequence Number: 13784235
• Product Code: FTL
• UDI-Device Identifier: 00643169468795
• UDI-Public: 00643169468795
• 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: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2016

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: 11/30/2015
• Device Model Number: CMRM6133
• Device Catalogue Number: CMRM6133
• Device Lot Number: 15K06650
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2016
• Initial Report FDA Received Date: 09/19/2017
• 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: 459888 LEAD, 5076-52 LEAD, 6935M62 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 68