MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE SCS SYSTEM; SCS IPG

Model Number	EVOKE CLOSED LOOP STIMULATOR (CLS) (US)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient with an implanted evoke spinal cord stimulation (scs) system exhibited an infection near their implant site.The scs system was explanted and the patient was reported to be recovering.
Additional Manufacturer Narrative
Investigation of this event is in progress.Once the investigation is complete, a supplemental report will be submitted.
Additional Manufacturer Narrative
Section d4 - expiration date section g - date received by manufacturer section g6 - type of report section h4 - device manufacture date section h6 - evaluation codes section h10 - manufacturer narrative the device was discarded at the healthcare facility.Infection is a potential risk that comes with surgery.The evoke scs system surgical us surgical guide includes ¿infection that may require hospitalisation with intravenous antibiotic therapy¿ as a risk such that the patient may require surgery including explant.The manufacturing records were reviewed.Product met all requirements for release.

• Brand Name: EVOKE SCS SYSTEM
• Common Device Name: SCS IPG
• Manufacturer (Section D): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• Manufacturer (Section G): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• Manufacturer Contact: sadie mauser ; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• MDR Report Key: 19983310
• Report Number: 3021836309-2024-00296
• Device Sequence Number: 8083361
• Product Code: LGW
• UDI-Device Identifier: 09352307000759
• UDI-Public: 09352307000759
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: 06/24/2024
• Device Model Number: EVOKE CLOSED LOOP STIMULATOR (CLS) (US)
• Device Catalogue Number: 3042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown