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	Unspecified Infection (1930); Pain (1994); Chills (2191)
Date of Event	02/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: ddmb1d1 icd, implanted (b)(6) 2017.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 had pain, redness, chills, warmth, and purulent drainage at the site of the implant.The patient developed a cardiovascular implantable electronic device infection with the organism being coagular negative staphylococcus.The implantable cardioverter defibrillator (icd), right ventricular (rv) lead, right atrial (ra) lead, and antibacterial envelope were explanted.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.

• 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: 6470727
• Report Number: 3005619263-2017-00018
• Device Sequence Number: 371628
• Product Code: FTL
• UDI-Device Identifier: 00643169468795
• UDI-Public: 00643169468795
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K130943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2017

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: 02/28/2017
• Device Model Number: CMRM6133
• Device Catalogue Number: CMRM6133
• Device Lot Number: 16M16818
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: 02/21/2017
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: THE 5076-52 LEAD, 694765 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 76