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U.S. Department of Health and Human Services

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

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TYRX, INC. AIGIS-R LARGE MESH, SURGICAL, POLYMERIC Back to Search Results
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.
 
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Brand NameAIGIS-R LARGE
Type of DeviceMESH, 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 Key5421944
MDR Text Key38463034
Report Number3005619263-2016-00001
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130943
Number of Events Reported1
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 Received02/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2015
Device Model NumberCMRM6133
Device Catalogue NumberCMRM6133
Device Lot Number15H27636
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 Received02/26/2016
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

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