MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE CAP12 PERCUTANEOUS LEAD KIT - 90CM (US); SCS LEAD

Model Number	102879
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
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
During an impedance check performed for a patient implanted with a permanent evoke spinal cord stimulation (scs), disconnected electrodes were identified.The patient elected for explant of their evoke scs system to resolve the reported event.The impedance check was performed as part of routine device check before performing magnetic resonance imaging (mri).
Additional Manufacturer Narrative
Correction: section h6 - component code: originally reported as patient lead (3079), updated to electrical lead/wire (452).Additional information: section d4 - expiration date, unique identifier (udi) #.Section d9 - 9.Date returned to manufacturer, device returned to manufacturer.Section g3 - date received by manufacturer.Section g6 - type of report.Section h4 - device manufacture date.Section h6 - evaluation codes.Section h10 - manufacturer narrative.The event involves two (2) evoke cap12 percutaneous lead kit - 90cm from the same manufactured lot.Details for the second lead below: model #: 102879.Catalog#: 3009.Serial/lot #: (b)(6).Manufacture date: 3/11/2024.Expiration date: 3/11/2026.Two (2) leads were returned and will be referenced as lead 1 for electrodes 1-12 and lead 2 for electrodes 13-24.Visual inspection of lead 1 identified multiple conductor cable breaks at the proximal end of the lead.The lead did not pass functional testing with disconnected electrodes and shorted electrodes identified, confirming the complaint.The functional testing results are consistent with the observed conductor cable damage.The cause of the conductor cable damage to lead 1 is unable to be definitively determined.Lead 2 had no observable damage.The lead did not pass functional testing, with multiple disconnected electrodes and shorted electrodes.The root cause is traced to damage on the distal end of the leads.This cause of damage to the distal lead is not able to be definitively determined.Log files from the event date were reviewed and confirm electrode disconnection of e7 and e14.The evoke scs system clinical manual details impedance as, "an electrode with a cross through it has high impedance (> 4000 o) and may be disconnected.A disconnected electrode shows an impedance of 8 and cannot be used for stimulation.Measurement electrodes that are disconnected will not record valid ecaps.The evoke scs system mri guidelines provides the following language for conditional mri compatibility, "mri compatibility has not been determined for a system where the impedance of the lead shows disconnected or shorted channels.Impedance measurement must be performed to ensure no channels are disconnected or shorted prior to scanning.".

• Brand Name: EVOKE CAP12 PERCUTANEOUS LEAD KIT - 90CM (US)
• Common Device Name: SCS LEAD
• 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: 22524449
• Report Number: 3021836309-2025-00195
• Device Sequence Number: 8058564
• Product Code: LGW
• UDI-Device Identifier: 09352307001657
• UDI-Public: 09352307001657
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 09/12/2025

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: 03/11/2026
• Device Model Number: 102879
• Device Catalogue Number: 3009
• Device Lot Number: 9017072934
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2024
• 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: Female