MAUDE Adverse Event Report: TYRX, INC. AIGIS-R LARGE MESH, SURGICAL, POLYMERIC

Model Number CMRM6133

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

Patient Problem Unspecified Infection (1930)

Event Date 04/22/2016

Event Type  Injury  

Manufacturer Narrative

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

Manufacturer Narrative

Concomitant medical products: 503452 lead, implanted: (b)(6) 1997; 4068-45 lead, implanted: (b)(6) 1997. A good faith effort will be made to obtain the applicable information relevant to the report. 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 and vegetation on the right ventricular (rv) lead after a device exchange procedure with an absorbable envelope. The patient was treated with antibiotics and cultures were taken. The implantable pulse generator (ipg) system was removed and replaced. No further patient complications have been reported as a result of this event.

• Brand Name: AIGIS-R LARGE
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TYRX, INC.; 1 deer park dr.; suites g, e; monmouth jct NJ 08852
• Manufacturer (Section G): TYRX, INC.; 1 deer park dr.; suites g, e; monmouth jct NJ 08852
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mound view, MN 55112 ; 7635052036
• MDR Report Key: 6164115
• MDR Text Key: 104282742
• Report Number: 3005619263-2016-00054
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 02/29/2016
• Device Model Number: CMRM6133
• Device Catalogue Number: CMRM6133
• Device Lot Number: 16A07684
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/09/2016 Patient Sequence Number: 1

Treatment

ADDR01 IPG