MAUDE Adverse Event Report: MEDTRONIC, INC. AIGIS-R MEDIUM MESH, SURGICAL, POLYMERIC

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.

• Brand Name: AIGIS-R MEDIUM
• Type of Device: MESH, 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 Key: 7650667
• MDR Text Key: 112866211
• Report Number: 3005619263-2018-00061
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130943
• Number of Events Reported: 1
• 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 Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/31/2018
• Device Model Number: CMRM6122
• Device Catalogue Number: CMRM6122
• Device Lot Number: R098302
• 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 Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial