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	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943)
Date of Event	09/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a few days after implant of an implantable pulse generator (ipg) system and antibacterial envelope, there was itching, redness, inflammation at the implant site, and there was oozing through the skin.The physician felt there was a possible allergic reaction to the antibacterial envelope.Infection was also reported and testing for this was done.The ipg system and the envelope were removed.A request for additional information was made and it was learned that testing showed the patient did not have an infection.Additionally, testing was done by placing two substances on the opposite side of the patient's chest and the patient responded with the same symptoms.The physician determined the patient was not allergic to the antibacterial envelope, but was in fact allergic to the benzoin and matisol that was applied to the skin at the time of implant.The patient may be implanted with a lead less pacemaker in the future.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the product was returned and visual screening analysis was performed.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: 7930983
• Report Number: 3005619263-2018-00090
• Device Sequence Number: 1936977
• Product Code: FTL
• UDI-Device Identifier: 00763000101602
• UDI-Public: 00763000101602
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2019

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: 11/30/2018
• Device Model Number: CMRM6122
• Device Catalogue Number: CMRM6122
• Device Lot Number: R102165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 01/15/2019
• 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: 51 YR