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	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system was seen by the pain physician due to inadequate pain coverage which revealed multiple disconnected electrodes and shorts.Reprogramming was able to recover pain coverage.The patient underwent a lead revision procedure to resolve the disconnected electrodes.
Additional Manufacturer Narrative
The replaced lead and active anchor were returned to saluda for analysis.The lead failed functional testing due to 4 disconnected electrodes.Capacitance testing was performed which confirmed intermittent disconnections on two wires.Inspection of the lead under magnification confirmed two broken conductor wires and kinking at the proximal end of the lead, indicating that the lead had been closely routed to the edge of the closed loop stimulator (cls).A fluoroscopy image was viewed which confirmed the lead was routed closely to the cls and not given enough strain relief to prevent lead damage.The manufacturer's instructions for use (ifu) cautions that the lead should not be bent at the port entry of the cls header.The impedance logs collected at each visit were reviewed and confirmed that the disconnections appeared progressively over several months.The manufacturing records were reviewed.Product met all requirements for release with no anomalies identified.

• 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: 18318632
• Report Number: 3021836309-2023-00167
• Device Sequence Number: 20713121
• Product Code: LGW
• UDI-Device Identifier: 09352307000773
• UDI-Public: 09352307000773
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2023

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 Expiration Date: 02/01/2025
• Device Model Number: EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM
• Device Catalogue Number: 3008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2023
• 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