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

Model Number	EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM
Medical Device Problem Codes	High impedance (1291); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system running open loop programs reported to no longer be receiving adequate stimulation.The patient had been programmed in open loop previously due to disconnected electrodes.Troubleshooting was performed but unsuccessful.An x-ray was performed which revealed the leads had migrated.It was reported that the patient had experienced frequent falls, not related to saluda scs system.A revision procedure was performed, and the system was replaced.
Additional Manufacturer Narrative
The explanted spinal cord stimulation (scs) system was returned to saluda for analysis.Both anchors passed functional testing, with no migration noted with a reference lead.Reported frequent patient falls could have contributed to the reported event of lead migration.Lead migration or suboptimal placement, which may result in undesirable stimulation changes and requiring surgery (including revision, explant, and replacement) as a result is listed as a potential risk in manufacturer¿s instruction for use (ifu).Both leads failed functional testing due to multiple disconnected electrodes.The cause of the disconnections cannot be confirmed but due to the location of the damage, may have occurred during implanting procedure when securing the anchor.

• Brand Name: EVOKE SCS SYSTEM
• Common Device Name: SCS LEAD
• 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: 19122612
• Report Number: 3021836309-2024-00228
• Device Sequence Number: 18073040
• Product Code: LGW
• UDI-Device Identifier: 09352307001589
• UDI-Public: 09352307001589
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/16/2024

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: Health Professional
• Device Expiration Date: 08/03/2023
• Device Model Number: EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM
• Device Catalogue Number: 3008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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