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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TYRX, INC. AIGIS-R MEDIUM; MESH, SURGICAL, POLYMERIC
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TYRX, INC. AIGIS-R MEDIUM; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number CMRM6122
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/12/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant product(s): a 407645 lead, implanted: (b)(6) 2006; dtbb1d1 crtd, implanted: (b)(6)2017.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 or Problem Description
It was reported that an infection occurred.The cardiac resynchronization therapy defibrillator (crt-d) system was explanted and a temporary pacing system was implanted until the system can be replaced.No further patient complications have been reported as a result of this event.
 
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Brand Name
AIGIS-R MEDIUM
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
TYRX, INC.
1 deer park dr.
suites g, e
monmouth jct NJ 08852
MDR Report Key6783024
Report Number3005619263-2017-00043
Device Sequence Number187119
Product Code FTL
UDI-Device Identifier00643169468856
UDI-Public00643169468856
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K130943
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/12/2017
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 Date05/31/2017
Device Model NumberCMRM6122
Device Catalogue NumberCMRM6122
Device Lot Number17C28053
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/12/2017
Initial Report FDA Received Date08/09/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
1058T LEAD, 694765 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age66 YR
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