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

Model Number CMRM6133

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

Patient Problem Unspecified Infection (1930)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 1948 lead (x2), implanted (b)(6) 2011.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced a pocket infection four weeks after the implant of a cardiac resynchronization therapy pacemaker (crt-p) system with an absorbable envelope.The system was removed and the patient received a new system on the opposite side the following day.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: 11864309
• MDR Text Key: 251994739
• Report Number: 2182208-2021-02089
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00763000307882
• UDI-Public: 00763000307882
• 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: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/14/2021
• Device Model Number: CMRM6133
• Device Catalogue Number: CMRM6133
• Device Lot Number: R139842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2021
• Date Device Manufactured: 11/19/2020
• 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
• Treatment: W1TR01 CRT-P, 383069 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 88 YR