MAUDE Adverse Event Report: RICE CREEK MFG TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE; MESH, SURGICAL, POLYMERIC

Model Number CMRM6122INT

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

Patient Problems Erythema (1840); Unspecified Infection (1930)

Event Date 07/17/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 5076-58 lead, implanted: (b)(6) 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the right ventricular (rv) lead exhibited unstable thresholds and was explanted and replaced with a new rv lead and an absorbable envelope.Approximately two weeks later, the patient experienced skin redness around the incision site and an infection was reported.One of the patient's physicians noted that it may not be an infection, but instead it may have been a reaction to the absorbable envelope as the patient is suffering from a chronic condition.However, the patient did have a previous absorbable envelope implanted with no reaction.The implantable pulse generator (ipg) system with an absorbable envelope was explanted and will be replaced on a later date.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): RICE CREEK MFG; 7000 central ave ne; fridley MN 55432
• Manufacturer (Section G): RICE CREEK MFG; 7000 central ave ne; fridley MN 55432
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10388007
• MDR Text Key: 202502729
• Report Number: 6000030-2020-00187
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/15/2021
• Device Model Number: CMRM6122INT
• Device Catalogue Number: CMRM6122INT
• Device Lot Number: R131600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2020
• Date Device Manufactured: 05/20/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR