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 Code	Unspecified Infection (1930)
Date of Event	04/11/2017
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 the implantable pulse generator (ipg) system was removed due to an infection.The patient was having an upgrade procedure from an ipg to an implantable cardioverter defibrillator (icd) and when the physician opened the pocket, yellow drainage was noticed in the pocket.Cultures were taken.No further patient complications have been reported as a result of this event.It was further reported that the implantable pulse generator (ipg) had been implanted with an absorbable envelope.It was also further reported that the aerobic culture tested positive for propionibacterium acnes.
Additional Manufacturer Narrative
Correction to g4 on initial report: should have been 30 may 2019.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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: 8694706
• Report Number: 3005619263-2019-00022
• Device Sequence Number: 14071649
• Product Code: FTL
• UDI-Device Identifier: 00643169468795
• UDI-Public: 00643169468795
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/29/2020

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: 11/30/2016
• Device Model Number: CMRM6133
• Device Catalogue Number: CMRM6133
• Device Lot Number: 16K21787
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2017
• Supplement Date Received by Manufacturer: 02/29/2020
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 02/29/2020
• 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, 5076-52 LEAD, 5076-45 LEAD; A2DR01 IPG, 5076-52 LEAD, 5076-45 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 102