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

Model Number	NMRM6122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	04/22/2019
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 approximately ten weeks post implant the patient had been feeling pain, and presented with open sores/wounds near the site of their gastro-urinary implantable pulse generator (ipg) system.Cultures for bacterial viral and gram stain were sent for evaluation and both have returned negative at this time.It was indicated that a consult from a physician stated the patient could possibly have had a "possible reaction to the titanium of the battery." it was noted that the patients one month follow up showed no issues.The device system had been implanted with a antibacterial absorbable envelope and it was thought that it could have possibly been protecting the patient from the reaction until the antibacterial absorbable envelope started to absorb.The ipg system was extracted due to a possible infection.No further patient complications have been reported as a result of this event.

• 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 Key: 8552335
• Report Number: 2182208-2019-00791
• Device Sequence Number: 16576850
• Product Code: FTL
• UDI-Device Identifier: 00763000101626
• UDI-Public: 00763000101626
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2019

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 Date: 02/28/2019
• Device Model Number: NMRM6122
• Device Catalogue Number: NMRM6122
• Device Lot Number: R107990
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3058, URINARY IPG / 3889-28, URINARY LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR