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

Model Number	NMRM6133
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Tissue Damage (2104); Discomfort (2330)
Date of Event	09/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products - model: 37603, dbs ipg; implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a patient that had a deep brain stimulation implantable pulse generator (ipg) implanted along with a absorbable antibacterial envelope.The patient had reported discomfort at the at the implant site and approximately nine months post implant a pocket revision was completed.When the surgeon opened the incision they found that the absorbable antibacterial envelope had fused to the underlying tissue.The surgeon had to cut away the tissue and extension in order to remove the envelope.The ipg was placed back into the pocket and an antibiotic powder was placed in the pocket and the incision was closed.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: 7930662
• Report Number: 3005619263-2018-00089
• Device Sequence Number: 16593695
• Product Code: FTL
• UDI-Device Identifier: 00643169624795
• UDI-Public: 00643169624795
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K150291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 10/04/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2017
• Device Model Number: NMRM6133
• Device Catalogue Number: NMRM6133
• Device Lot Number: 17K26198
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 10/04/2018
• 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: 3387S-40, DBS LEAD / 3708660, NEURO EXTENSION
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 83