MAUDE Adverse Event Report: Medtronic Neuromodulation TYRX Absorbable Antibacterial Envelope; MESH, SURGICAL, POLYMERIC

Model Number	CMRM6122
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported one day after implant that the right atrial (ra) lead exhibited dislodgement, high impedance and polarity switch.The right ventricular (rv) lead exhibited high impedance, polarity switch, and oversensing.The ra lead was repositioned and the rv lead remained in use.It was further reported five days after implant that the patient experienced an infection.The implantable pulse generator (ipg) system and antibacterial absorbable envelope were explanted seven days after implant.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
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 MN 55432
• Manufacturer (Section G): Medtronic Neuromodulation; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(763)526-9277
• MDR Report Key: 50402902
• Report Number: 2182208-2026-50034
• Device Sequence Number: 15746493
• Product Code: FTL
• UDI-Device Identifier: 00763000307875
• UDI-Public: (01)00763000307875(17)270514(10)R276492
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K130943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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 Model Number: CMRM6122
• Device Catalogue Number: CMRM6122
• Device Lot Number: R276492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Date Device Manufactured: 05/19/2026
• 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: W1DR01 IPG, 5076-58 LEAD, 5076-58 LEAD.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male