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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 Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 04/17/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: model: 5076-52, lead; implanted: (b)(6) 2020.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was further reported that a antibacterial absorbable envelope was in use at the time of the infection.The antibacterial absorbable envelope was removed at the same time the implantable cardioverter defibrillator (icd) system was extracted.
 
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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 Key10163701
Report Number2182208-2020-01118
Device Sequence Number2653917
Product Code FTL
UDI-Device Identifier00763000101619
UDI-Public00763000101619
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K130943
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/17/2020
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 Date02/29/2020
Device Model NumberCMRM6133
Device Catalogue NumberCMRM6133
Device Lot NumberR123739
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/27/2020
Initial Report FDA Received Date06/17/2020
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
6947M62, LEAD/DDMB1D4, ICD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age70 YR
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