MAUDE Adverse Event Report: MEDTRONIC IRELAND ARES

Model Number	95001
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/25/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient experienced an infection in the brain as seen post shunt implant procedure.It is unknown if there was any intervention planned, if the product was damaged, or how the procedure was completed.The patient is noted to be deceased.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that the surgery was performed in (b)(6) 2020, and the case of infection was reported almost 3 months later.When the surgeon was asked if the device was the cause of the infection and if they planned to explant the device, the surgeon stated no.The surgeon has been unwilling to disclose any further information.It was indicated that the device was still implanted when the patient passed away.

• Brand Name: ARES
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11485888
• Report Number: 9612164-2021-01004
• Device Sequence Number: 11620534
• Product Code: JXG
• UDI-Device Identifier: 00643169762664
• UDI-Public: 00643169762664
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: No Information
• Device Expiration Date: 05/06/2021
• Device Model Number: 95001
• Device Catalogue Number: 95001
• Device Lot Number: 0010001448
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 2 YR