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U.S. Department of Health and Human Services

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

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TYRX, INC. AIGIS MESH, SURGICAL, POLYMERIC Back to Search Results
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.
 
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Brand NameAIGIS
Type of DeviceMESH, 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 Key6783740
MDR Text Key82508937
Report Number3005619263-2017-00045
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received08/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTYRX-AAE
Device Catalogue NumberTYRX-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 Received05/06/2017
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

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