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

Model Number CMRM6133

Device Problem Product Quality Problem (1506)

Patient Problem Erosion (1750)

Event Date 02/17/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 5071-35 lead, implanted: (b)(6) 2010; 6945-65 lead, implanted: (b)(6) 1998.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 the antibacterial envelope did not absorb and caused erosion through the skin when the device moved laterally.It was also reported the device migrated and eroded through the skin.It was noted this was due to the patient losing a lot of weight.The envelope was removed and the device was re-positioned back into the pocket.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis determined to not be required.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• 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; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6467523
• MDR Text Key: 72058903
• Report Number: 3005619263-2017-00013
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2016
• Device Model Number: CMRM6133
• Device Catalogue Number: CMRM6133
• Device Lot Number: 16A20687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2017
• Initial Date FDA Received: 04/06/2017
• Supplement Dates Manufacturer Received: 05/30/2017; 05/30/2017
• Supplement Dates FDA Received: 08/09/2017; 10/02/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2016
• 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: DTBB1D1 ICD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR