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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 Code Unspecified Infection (1930)
Date of Event 02/28/2018
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 implantable pulse generator (ipg) system was explanted due to infection.Cultures were taken, and antibiotic treatment was necessary.It was also reported that the antibiotic envelope was infected, and it envelope remains in use.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 Key7335798
Report Number2182208-2018-00331
Device Sequence Number698047
Product Code FTL
UDI-Device Identifier00643169935891
UDI-Public00643169935891
Combination Product (Y/N)N
Initial Reporter StateWI
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) 03/13/2018
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 Date12/31/2017
Device Model NumberCMRM6122
Device Catalogue NumberCMRM6122
Device Lot NumberR092190
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/28/2018
Initial Report FDA Received Date03/13/2018
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
A2DR01 IPG, 5076-52 LEAD, 5076-45 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age76 YR
Patient Weight83
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