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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 11/13/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products- model: w1dr01, implantable pulse generator (ipg); implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient had developed a pocket infection after a recent implantable pulse generator (ipg) changeout procedure where a absorbable antibacterial envelope had been utilized.The ipg and leads have been extracted.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 Key8134232
Report Number2182208-2018-02202
Device Sequence Number1693673
Product Code FTL
UDI-Device Identifier00763000101602
UDI-Public00763000101602
Combination Product (Y/N)N
Initial Reporter StateNH
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) 12/05/2018
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 Date09/30/2018
Device Model NumberCMRM6122
Device Catalogue NumberCMRM6122
Device Lot NumberR100697
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/13/2018
Initial Report FDA Received Date12/05/2018
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
4592-53, LEAD / 4092-58, LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age67 YR
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