MAUDE Adverse Event Report: TYRX, INC. TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE; MESH, SURGICAL, POLYMERIC

Model Number CMRM6133

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Discomfort (2330)

Event Date 08/11/2021

Event Type  Injury  

Event Description

It was reported that the patient presented with tenderness around the implant site.It was noted four days earlier the device had been repositioned because of the tenderness and there was a lot of blood and scar tissue noted during the procedure.Intravenous and oral antibiotics were administered.Four days later a deep incisional surgical site infection was confirmed, and an additional revision was done.An antibacterial absorbable envelope was used.During both revisions the pocket was cleaned out and cultures were taken.Positive blood cultures for enterobacter cloacae were found.The device remains in use.The patient is a participant in a clinical study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: product id: 6935m62, implanted (b)(6) 2015; product id: 5076-52, product type: lead, implanted (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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.

Event Description

It was later clarified that when the revision was done the original antibacterial absorbable envelope was washed out with antibiotic solution when the pocket was cleaned.A second antibacterial absorbable envelope was used and remained in use.

• Brand Name: TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TYRX, INC.; 1 deer park dr.; suites g, e; monmouth jct NJ 08852
• Manufacturer (Section G): TYRX, INC.; 1 deer park dr.; suites g, e; monmouth jct NJ 08852
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 14117388
• MDR Text Key: 289324915
• Report Number: 3005619263-2022-00007
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: CMRM6133
• Device Catalogue Number: CMRM6133
• Device Lot Number: CMRM6133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 04/18/2022
• Supplement Dates FDA Received: 04/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DTMB1QQ CRTD, 439888 LEAD.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White