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 Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pocket Erosion (2013)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a little over one month post implant of an implantable cardioverter defibrillator (icd) system with an antibacterial absorbable envelope the patient presented with puss and oozing at the pocket site.The patient was negative for a systemic infection and was noted to have a normal white blood cell count.The physician suspected that the patient may be experiencing an allergic reaction in the patients pocket causing pocket erosion.The icd system was explanted and replaced one week later with a leadless pacemaker.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: 11618963
• MDR Text Key: 243924890
• Report Number: 2182208-2021-01337
• 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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/21/2021
• Device Model Number: CMRM6133
• Device Catalogue Number: CMRM6133
• Device Lot Number: R129032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2021
• Date Device Manufactured: 03/26/2020
• 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: DDMB1D4 ICD, 383069 LEAD, 6935M62 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR