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

Model Number	EVOKE ACTIVE ANCHOR KIT (US)
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported turning over in bed and feeling a popping sensation at the spine incision site.An x-ray revealed the implanted leads had migrated.A revision procedure was completed replacing the leads and anchors.Following the revision procedure, the patient was programmed into closed-loop therapy with adequate pain relief.

• Brand Name: EVOKE SCS SYSTEM
• Common Device Name: SCS ACTIVE ANCHOR
• Manufacturer (Section D): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• MDR Report Key: 18389821
• Report Number: 3016111136-2023-00137
• Device Sequence Number: 19501820
• Product Code: LGW
• UDI-Device Identifier: 09352307000810
• UDI-Public: 09352307000810
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/23/2023
• Report Date (Section F): 12/01/2023

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: Health Professional
• Device Model Number: EVOKE ACTIVE ANCHOR KIT (US)
• Device Catalogue Number: 3043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown