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

Model Number CMRM6133

Device Problem Use of Device Problem (1670)

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

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. (b)(4).

Event Description

It was reported that as the physician was closing the pocket following lead implant, the atrial lead dislodged. The physician attempted to reposition the lead but the pacing threshold never improved. The physician believed there was difficulty extending and retracting the helix. The study investigator noted that the event was related to the procedure and the atrial lead. The lead was explanted and replaced. It was further reported that the physician wondered about the absorbable envelope "grabbing" the leads when placed in the pocket causing micro dislodgement and then atrial lead dislodgement with defibrillation threshold (dft) testing. The physician thought perhaps they had probably too much lead length in pocket, wrapped implantable plus generator (ipg) only and could see how ipg going in could have potentially grabbed pulled the lead. The absorbable envelope was implanted. The patient was enrolled in the (b)(6) clinical study. No patient complications have been reported as a result of this event.

Manufacturer Narrative

Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. 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 further reported that the physician struggled with getting the envelope into the pocket, and suggested that it was the struggle which caused the atrial lead to dislodge. Prior to placing the ipg with envelope into the pocket, the atrial lead had tested within normal parameters through the analyzer. After placing the ipg and envelope in the pocket it seemed that the atrial lead was sensing in the right ventricle. Fluoroscopy was used to verify dislodgement.

• 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: 5421944
• MDR Text Key: 38463034
• Report Number: 3005619263-2016-00001
• 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

• Type of Report: Initial,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2015
• Device Model Number: CMRM6133
• Device Catalogue Number: CMRM6133
• Device Lot Number: 15H27636
• 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: 02/26/2016
• 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