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
Additional Manufacturer Narrative
The device was not returned to saluda for analysis, therefore it is not possible to reach a definitive root cause. the reported lead migration was confirmed via review of x-ray imaging provided.Lead migration which may result in undesirable stimulation changes is listed as a potential risk in clin-uman-005177 evoke scs system surgical guide usa-pma.Based on the event description, some movement by the patient appears to have facilitated the migration.The manufacturing records were reviewed.Product met all requirements for release with no anomalies identified.
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
• 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: 18406552
• Report Number: 3021836309-2023-00176
• Device Sequence Number: 14118136
• Product Code: LGW
• UDI-Device Identifier: 09352307000810
• UDI-Public: 09352307000810
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 12/27/2023
• 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