MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE; MESH, SURGICAL, POLYMERIC

Model Number	CMRM6122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported approximately one month post implant that the patient developed a pocket infection post hematoma.The implantable pulse generator (ipg) system was explanted and replaced with an leadless implantable pulse generator (ipg).No further patient complications have been reported as a result of this event.It was further reported that the hematoma was evacuated prior to infection.It was further reported that an antibacterial absorbable envelope was placed during the implant procedure.
Additional Manufacturer Narrative
H11: this regulatory report is being submitted as part of a retrospective review and remediation related to capa 711948.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Corrected: d.3, d.4, h.2.4, g.1 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis 55432
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway, MN 55112--439 ; EI 55112-4391 ; +353 7635269277
• MDR Report Key: 24663676
• Report Number: 2182208-2026-11762
• Device Sequence Number: 18452449
• Product Code: FTL
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/26/2026

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: 02/22/2024
• Device Model Number: CMRM6122
• Device Catalogue Number: CMRM6122
• Device Lot Number: R209946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 05/13/2025; 05/26/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/13/2026; 05/26/2026
• Date Device Manufactured: 02/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5076-58 LEAD, 5076-52 LEAD, W1DR01 IPG
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 207 LB