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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. AIGIS-R MEDIUM; MESH, SURGICAL, POLYMERIC
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MEDTRONIC, 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 Codes Unspecified Infection (1930); Impaired Healing (2378)
Date of Event 02/12/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patients implant incision did not heal and the patient developed an infection.The implantable cardioverter defibrillator (icd) and right ventricular (rv) lead were extracted.It was noted that a antibacterial absorbable envelope was initially implanted with the icd system.Cultures were taken and antibiotic treatment was necessary.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)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key8373861
Report Number2182208-2019-00371
Device Sequence Number1332265
Product Code FTL
UDI-Device Identifier00763000101602
UDI-Public00763000101602
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K130943
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/27/2019
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 Date09/30/2018
Device Model NumberCMRM6122
Device Catalogue NumberCMRM6122
Device Lot NumberR100635
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/12/2019
Initial Report FDA Received Date02/27/2019
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
6935M62, LEAD / DVFB1D4, ICD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age50 YR
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