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

Model Number	NMRM6122
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Rash (2033)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products- model: qty.2 / 97715, pain stim ipg; implanted: (b)(6) 2019 model: qty.2 / 3888-56, pain stim lead; implanted: (b)(6) 2017 model: 3777-60, pain stim lead; implanted: (b)(6) 2017 model: 3708220, extension kit; implanted: (b)(6) 2017 model: 3708220, extension kit; implanted: (b)(6) 2016.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that after a recent pain stim implantable pulse generator (ipg) changeout the patient had developed a rash around the implant sites.It was noted that antibacterial absorbable envelopes were utilized with the implants.An intervention procedure was completed to remove the antibacterial absorbable envelopes and the patients rash cleared/went away.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: 8539780
• Report Number: 2182208-2019-00767
• Device Sequence Number: 19268637
• Product Code: FTL
• UDI-Device Identifier: 00763000101626
• UDI-Public: 00763000101626
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K130943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2019

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: 03/31/2019
• Device Model Number: NMRM6122
• Device Catalogue Number: NMRM6122
• Device Lot Number: R109642
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 04/23/2019
• 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: 3888-56, PAIN STIM LEAD / 3777-60, PAIN STIM LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 37 YR