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

Model Number CMRM6133INT

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

Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient developed an infection while implanted with an antibacterial absorbable envelope and a competitor cardiac resynchronization therapy pacemaker (crt-p) system.The infection was identified as staphylococcus aures, and the patient was treated with antibiotics.The envelope remains implanted.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: 9728287
• MDR Text Key: 180616505
• Report Number: 2182208-2020-00326
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K130943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2020
• Device Model Number: CMRM6133INT
• Device Catalogue Number: CMRM6133INT
• Device Lot Number: R120073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2020
• Date Device Manufactured: 09/23/2019
• 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
• Patient Outcome(s): Required Intervention