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

Model Number	EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM (US)
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported their scs system program was no longer working.It was identified that the system had disconnected electrodes.The patient's system was reprogrammed with two closed-loop programs.The programs did not provide the stability desired, so the patient underwent a revision procedure.All impedances were in range and the patient's therapy was restored following the procedure.
Additional Manufacturer Narrative
Investigation of this event is in progress.Once the investigation is complete, a supplemental report will be submitted.
Additional Manufacturer Narrative
The closed loop stimulator (cls), lead, and active anchor were returned for analysis.The lead failed functional testing due to multiple disconnected electrodes.The lead was inspected under magnification and multiple broken conductor wires were noted at the location of a kink immediately distal of the anchor fixation site.The cause of the break in conductor wires was not definitively determined, but implant technique likely contributed to the damage regarding the kink in the lead.When performing impedance checks on the cls, the device failed both impedance checks but passed all other testing.The impedance issues observed align with expected damage from electrocautery use.Saluda personnel advised that electrocautery was used to open to cls pocket during the revision surgery.The manufacturing records were reviewed.The 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 their scs system program was no longer working.It was identified that the system had disconnected electrodes.The patient's system was reprogrammed with two closed-loop programs.The programs did not provide the stability desired, so the patient underwent a revision procedure.All impedances were in range and the patient's therapy was restored following the procedure.

• 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: 18451654
• Report Number: 3021836309-2024-00178
• Device Sequence Number: 12654152
• Product Code: LGW
• UDI-Device Identifier: 09352307000087
• UDI-Public: 09352307000087
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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 (US)
• Device Catalogue Number: 3008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 02/15/2024
• 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: Male