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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
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 03/25/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a pocket infection occurred.The patient was treated with antibiotics and the cardiac resynchronization therapy defibrillator (crt-d) system and envelope was explanted.No further patient complications have been reported as a result of this event.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
AIGIS-R LARGE
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
TYRX, INC.
1 deer park dr.
suites g, e
monmouth jct NJ 08852
MDR Report Key6624061
Report Number3005619263-2017-00023
Device Sequence Number106377
Product Code FTL
UDI-Device Identifier00643169468795
UDI-Public00643169468795
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K130943
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/25/2017
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? No
Operator of Device Lay User/Patient
Device Expiration Date03/31/2017
Device Model NumberCMRM6133
Device Catalogue NumberCMRM6133
Device Lot Number17B03021
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/25/2017
Supplement Date Received by Manufacturer03/25/2017
Initial Report FDA Received Date06/08/2017
Supplement Report FDA Received Date10/03/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age58 YR
Patient Weight121
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