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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
Device Problem Device Expiration Issue (1216)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products - model: w1sr01, implantable pulse generator (ipg); implanted: (b)(6) 2018. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during an implantable pulse generator (ipg) changeout procedure an antibacterial envelope was utilized. It was discovered post implant that the envelope was past the use before date (ubd). The device remains implanted. No patient complications have been reported as a result of this event.
 
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Brand NameAIGIS-R MEDIUM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
suites g, e
mounds view,mn NJ 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
suites g, e
mounds view,mn NJ 55112
Manufacturer Contact
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key7650667
MDR Text Key112866211
Report Number3005619263-2018-00061
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130943
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2018
Device Model NumberCMRM6122
Device Catalogue NumberCMRM6122
Device Lot NumberR098302
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/17/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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