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

Model Number CMRM6133

Device Problem Use of Device Problem (1670)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 407645 lead, implanted: (b)(6) 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that while closing the pocket at the end of the implant procedure, the physician noted that the right ventricular (rv) lead thresholds had risen and ectopy was observed.It was determined that the rv lead and the left ventricular (lv) lead had dislodged due to the rv being sewn to the antibacterial absorbable envelope and the muscle.The rv lead was also exhibiting no capture.Repositioning of the rv lead was attempted but unsuccessful, so the rv lead was capped and replaced.The lv lead was explanted and replaced.The antibacterial absorbable envelope remains in the patient.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: 11619385
• MDR Text Key: 243943905
• Report Number: 2182208-2021-01341
• 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: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: CMRM6133
• Device Catalogue Number: CMRM6133
• Device Lot Number: R128775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2021
• Date Device Manufactured: 03/20/2020
• 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
• Treatment: 6935M55 LEAD, 479888 LEAD, DTMA1QQ CRT-D
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR