MAUDE Adverse Event Report: TYRX, INC. AIGIS-R MEDIUM; MESH, SURGICAL, POLYMERIC

Model Number	CMRM6122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 407658 lead, implanted: (b)(6) 2011, 5076-52 lead, implanted: (b)(6) 2011.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 an implant site infection limited to cellulitis approximately three weeks after the implant of an implantable pulse generator (ipg) with absorbable envelope.The patient called their physician's office and complained of drainage at the incision site.The patient was instructed to go to the emergency department (ed) for evaluation.The patient stated the ed physician said the incision did not look infected and sent the patient home.A week later the patient called their physician's office again regarding clear fluid draining.The patient was treated with oral antibiotics.The implantable pulse generator (ipg) remains in implanted and in use.The patient is a participant in the (b)(6) study.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 MEDIUM
• 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: 6477933
• Report Number: 3005619263-2017-00020
• Device Sequence Number: 18923525
• Product Code: FTL
• UDI-Device Identifier: 00643169468856
• UDI-Public: 00643169468856
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 01/04/2017

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: 12/31/2016
• Device Model Number: CMRM6122
• Device Catalogue Number: CMRM6122
• Device Lot Number: 16K25789
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: 01/04/2017
• Initial Report FDA Received Date: 04/10/2017
• Supplement Report FDA Received Date: 09/14/2017
• 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: A2DR01 IPG
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 132