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 Problems Bruise/Contusion (1754); Hematoma (1884); Swelling/ Edema (4577)

Event Date 06/06/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 6725 adaptor, implanted (b)(6) 2021.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient's implant site became swollen a few days post-cardiac resynchronization therapy defibrillator (crt-d) implant with an antibacterial absorbable envelope.Bruising and swelling increased after the patient fell a few days later.The patient was noted to be on anticoagulant medication.The pocket was opened and a hematoma evacuation was performed.The envelope was removed, a new envelope was inserted, and the crt-d remains in use.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: 12091274
• MDR Text Key: 259125508
• Report Number: 2182208-2021-02640
• 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: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/11/2022
• Device Model Number: CMRM6133
• Device Catalogue Number: CMRM6133
• Device Lot Number: R144176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2021
• Date Device Manufactured: 03/16/2021
• 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: DTPB2QQ CRT-D, 6935M55 LEAD, 459888 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 91 YR
• Patient Weight: 87