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

Model Number	CMRM6133
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.The event only occurred with one patient.Referenced article: recurrent rash over a cardiac implantable electronic device: a rare case of antibacterial envelope hypersensitivity.Heart rhythm case reports.2025.1¿5.Doi: 10.1016/j.Hrcr.2025.06.029 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.
Event or Problem Description
Literature was reviewed regarding antibacterial absorbable envelope hypersensitivity.The authors described a patient who underwent the implant of an extravascular (ev) implantable cardioverter defibrillator (icd) system with the use of an antibacterial absorbable envelope.During the procedure, it took four different substernal tunneling attempts to place the lead without p-wave oversensing which led to a prolonged procedure time.Approximately two weeks post implant, the patient developed a generalized rash which affected their upper extremities and limbs.Amiodarone was stopped and the rash resolved.Four weeks later, the patient developed a pruritic rash which resembled ¿bug bites¿ directly over the device pocket.The patient had no fever, pain, and no signs of hematoma, purulent drainage, or device erosion.The rash resolved with topical ointments.Over the next 2 weeks, the patient experienced recurrent episodes of localized pruritic rash over the device pocket, and it was suspected that the patient had an allergic reaction.Patch testing was performed, and the results showed a positive reaction to the antimicrobial agents in the antibacterial absorbable envelope.Twelve to sixteen weeks after the implantation, the rash had completely resolved, and the patient remained asymptomatic.The lead remains in use.No additional adverse patient effects or product performance issues were reported.

• Brand Name: TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view,mn
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view,mn
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 23009880
• Report Number: 2182208-2025-04482
• Device Sequence Number: 18767473
• Product Code: FTL
• UDI-Device Identifier: 00763000307882
• UDI-Public: (01)00763000307882(17)250503(10)R234925
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K130943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2025

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: 05/03/2025
• Device Model Number: CMRM6133
• Device Catalogue Number: CMRM6133
• Device Lot Number: R234925
• 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: 09/04/2025
• Initial Report FDA Received Date: 09/09/2025
• Date Device Manufactured: 05/08/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male