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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE; MESH, SURGICAL, POLYMERIC
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MEDTRONIC, INC. TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number CMRM6133
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 10/24/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: dtma1qq crt-d, implanted: (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient experienced an infection four weeks after the implant of a cardiac resynchronization therapy defibrillator (crt-d) with an absorbable envelope.The device was explanted.No further patient complications have been reported as a result of this event.
 
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Brand Name
TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key9350349
Report Number2182208-2019-02083
Device Sequence Number14153496
Product Code FTL
UDI-Device Identifier00763000101619
UDI-Public00763000101619
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
K130943
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/20/2019
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 Date11/30/2018
Device Model NumberCMRM6133
Device Catalogue NumberCMRM6133
Device Lot NumberR104672
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/30/2019
Initial Report FDA Received Date11/20/2019
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 Age57 YR
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