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

Model Number	EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evoke spinal cord stimulation (scs) system remains implanted.The cause of pain in patient's rib area remains unknown.According to the physician, the lead could have been agitating a nearby nerve root potentially causing the reported patient symptoms.A revision procedure was performed to reposition the lead which resolved the reported patient symptom.Post revision procedure, the patient has been receiving adequate therapy.The manufacturing records were reviewed.Product met all requirements for release with no anomalies identified.The patient has been implanted with two evoke cap12 percutaneous lead kit - 60cm.It is not possible to determine which lead was causing the reported patient symptom.Information for both leads has been listed below: section d4 lot number - 9015604946 or 9015775161.9015604946: device expiration date: 16-may-2025.Device manufacture date: 17-may-2023 (section h4).9015775161: device expiration date: 20-june-2025.Device manufacture date: 21-june-2023 (section h4).
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported pain in their rib area.X-ray imaging revealed the right lead may have been agitating the nearby nerve root.Oral steroids were administered to address any inflammation, but the symptoms did not resolve.A revision procedure was performed to reposition the lead.After the procedure, the patient was no longer experiencing rib pain and is receiving adequate therapy.

• 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: 19052428
• Report Number: 3021836309-2024-00225
• Device Sequence Number: 8188117
• Product Code: LGW
• UDI-Device Identifier: 09352307000773
• UDI-Public: 09352307000773
• 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
• 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): 04/05/2024

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 Model Number: EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM
• Device Catalogue Number: 3008
• 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: 03/11/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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