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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 CMRM6133EU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Endocarditis (1834); Low Blood Pressure/ Hypotension (1914); Septic Shock (2068); Weakness (2145); Multiple Organ Failure (3261)
Event Date 12/05/2016
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was further reported that according to a clinical events committee (cec) assessment this event is implant related and related to a cardiovascular implantable electronic device (cied) infection identified as endocarditis.
 
Manufacturer Narrative
Concomitant product: model: 439888, lead; implanted: (b)(6) 2016.
 
Event Description
It was reported that a patient enrolled in the (b)(6) is deceased associated to septic shock. It was further reported the patient had left and right cardiac failure and polyorganic failure. The patient was treated with intravenous antibiotics. Blood cultures were found to be negative and the source of the sepsis is unknown.
 
Manufacturer Narrative
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 patient felt weakness and had hypotension.
 
Manufacturer Narrative
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.
 
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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)
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 Key6227290
MDR Text Key126298745
Report Number3005619263-2017-00001
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K130943
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2017
Device Model NumberCMRM6133EU
Device Catalogue NumberCMRM6133EU
Device Lot Number16K10783
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 Received11/01/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/10/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/05/2017 Patient Sequence Number: 1
Treatment
DTBC2QQ , CRT-D / 5076-52, LEAD / 6947M62, LEAD
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