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 Codes	Hematoma (1884); Unspecified Infection (1930); Impaired Healing (2378)
Date of Event	03/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 approximately one month post implant of the implantable pulse generator (ipg) system, a pocket revision and implant of an absorbable antibacterial envelope was performed due to excoriation and medial edge of pocket incision failed to heal with non-union.At clinic follow up the ipg site was not healing and a hematoma was noted along with an opening in the incision.It was further reported that infection was suspected.The implantable pulse generator (ipg) system was 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 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: 6625282
• Report Number: 3005619263-2017-00030
• Device Sequence Number: 87245
• Product Code: FTL
• UDI-Device Identifier: 00643169468856
• UDI-Public: 00643169468856
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K130943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2017

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: 03/31/2017
• Device Model Number: CMRM6122
• Device Catalogue Number: CMRM6122
• Device Lot Number: 17B17028
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2017
• Supplement Date Received by Manufacturer: 03/30/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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: 71 YR
• Patient Weight: 101