MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE CLOSED LOOP STIMULATOR (CLS) (US); SCS IPG

Model Number	EVOKE CLOSED LOOP STIMULATOR (CLS) (US)
Medical Device Problem Codes	Mechanical Problem (1384); Inappropriate/Inadequate Shock/Stimulation (1574); Biocompatibility (2886)
Health Effect - Clinical Codes	Device Overstimulation of Tissue (1991); Inadequate Pain Relief (2388)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation of this event is in progress.Once the investigation is complete, a supplemental report will be submitted.
Event or Problem Description
A patient was implanted with an evoke spinal cord stimulation (scs) system and had adequate pain coverage.Fourteen months later, the patient underwent an unrelated lumbar spinal fusion surgery with hardware implanted.Following the procedure the patient reported inadequate pain relief.During re-programming, the patient reported pain and disconnected electrodes were identified.The lead was damaged by the hardware placed during the previous surgery.The system was revised which resolved the issue.
Additional Manufacturer Narrative
Correction: section a1 - patient identifier.Section h6.Medical device problem code.Patient- removed "device incompatibility: biocompatibility (b)(6)".Additional information: section d4 - expiration date, unique identifier (udi) # section g - date received by manufacturer.Section g6 - type of report.Section h4 - device manufacture date.Section h6 - evaluation codes.Section h10 - manufacturer narrative.The closed loop stimulator (cls) was returned for analysis.There was no physical damage visible on the cls.The cls failed functional testing due to several impedance issues noted during electrical output testing.Impedance logs were reviewed for several dates, including the date of the revision procedure.Log review noted comparable impedances with a drop in impedances that onset partway through the date of the revision procedure.The cls electrical testing results and impedance log review are potentially consistent with damage caused by electrocautery usage, when this was confirmed in other instances.The rep was unable to confirm electrocautery usage.The root cause of the cls analysis results cannot be definitively determined.The leads were not returned for analysis.Impedance logs were reviewed and compared from before and after the date that the lumbar surgery was completed.Multiple short electrodes were confirmed after the date of the lumbar surgery.Per the initial event report, the leads were damaged from hardware used during the lumbar surgery.The reported lead damage and decrease in stimulation were confirmed.Device information of the shorted electrodes.Brand name - evoke cap12 percutaneous lead kit - 60cm.Model - 102878.Catalog - 3008.Lot number - 9015055877.Expiration date - 01-february-2025.Manufacture date - 02-february-2023.Udi - (b)(4).

• Brand Name: EVOKE CLOSED LOOP STIMULATOR (CLS) (US)
• Common Device Name: SCS IPG
• Manufacturer (Section D): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw 2113 ; AU 2113
• Manufacturer (Section G): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw - ; AU -
• Manufacturer Contact: sadie mauser ; 5 eden park drive; macquarie park, nsw - ; AU -
• MDR Report Key: 20267988
• Report Number: 3021836309-2024-00009
• Device Sequence Number: 7315330
• Product Code: LGW
• UDI-Device Identifier: 09352307000292
• UDI-Public: 09352307000292
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 11/21/2024

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: 06/17/2024
• Device Model Number: EVOKE CLOSED LOOP STIMULATOR (CLS) (US)
• Device Catalogue Number: 3002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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