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

Model Number CMRM6133

Device Problem Device Expiration Issue (1216)

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

Event Date 09/03/2014

Event Type  malfunction  

Event Description

It was reported that the envelope was implanted three days after the expiration date.The envelope remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Concomitant product: 2 - 1888tc st.Jude leads, implanted: (b)(6) 2008.(b)(4).

• 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): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4319125
• MDR Text Key: 21173415
• Report Number: 3005619263-2014-00014
• Device Sequence Number: 1
• Product Code: FTL
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2014
• Device Model Number: CMRM6133
• Device Catalogue Number: CMRM6133
• Device Lot Number: 14F25473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2015
• Initial Date FDA Received: 12/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/09/2015
• Date Device Manufactured: 06/25/2014
• 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: C4TR01, IPG, 6725, ADAPTOR
• Patient Age: 00085 YR