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

Model Number TYRX-AAE

Device Problem Impedance Problem (2950)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: a 7120 lead, implanted: (b)(6)2009, 5071-53 x2 leads, implanted: (b)(6)2008, 5076-45 lead, implanted: (b)(6)2007. 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 one day after a routine device replacement procedure, the new device was measuring the right ventricular (rv) pacing impedance high as well as the rv defibrillation, superior vena cava (svc), and left ventricular impedances. Follow-up clarified that the physician attributed the high impedance measurements to the absorbable envelope, not the device nor leads. The alerts were programmed off, the physician elected to follow-up with the patient in one week; the envelope remains in use. No patient complications have been reported as a result of this event.

• Brand Name: AIGIS
• 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; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6783740
• MDR Text Key: 82508937
• Report Number: 3005619263-2017-00045
• 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,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/06/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: TYRX-AAE
• Device Catalogue Number: TYRX-AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/06/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial