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

Model Number TYRX-AAE

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

Patient Problems Erythema (1840); Fever (1858); Unspecified Infection (1930); Tachycardia (2095); Chills (2191)

Event Date 09/19/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that approximately three weeks post implant the patient was suspected to have developed an infection.It was further reported that the implantable pulse generator (ipg) site was very tender with severe erythema and had some serosanguinous drainage.It was further reported that the patient had a fever and tachycardia.The patient complained of not feeling well and having chills.The patient received intravenous (iv) antibiotics.Pocket drainage was performed and a temporary right ventricular (rv) lead connected to an external pacemaker was used.Blood and wound cultures were positive for staphylococcus aureus.It was also reported that an antibacterial absorbable envelope had been originally implanted with the ipg system.The ipg system was explanted and replaced with a leadless ipg. the patient is a participant in the post approval clinical surveillance product surveillance registry.No further patient complications have been reported as a result of this event.

• Brand Name: TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 12622660
• MDR Text Key: 276100606
• Report Number: 2182208-2021-04067
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2021

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: TYRX-AAE
• Device Catalogue Number: TYRX-AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/13/2021
• 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: W1DR01 IPG, 383069 LEAD, 5076-45 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 73