MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE CHARGER KIT (US); SCS CHARGER

Model Number	101147
Medical Device Problem Codes	Failure to Charge (1085); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to saluda for analysis.The charger successfully powered on when connected to a wall adapter; however, the charger did not remain operational once disconnected from the wall adapter.The device case was opened.Visual inspection of the lithium-ion battery component was consistent with thermal runaway.Thermal markings were observed surrounding the battery compartment.The remainder of the internal components, including the pcba were intact and undamaged.Following replacement of the charger battery component, the charger passed functional testing and performed as intended.The root cause of the reported event is traced to the battery component.Safety features related to device temperature were confirmed to be intact, with no anomalies observed.The evoke scs system user manual states, "the charger unit may become hot during use, with a surface temperature reaching 48 °c (118 °f).Do not hold the charger unit for longer than 10 minutes during use." the manufacturing records were reviewed, and the product met all requirements for release with no anomalies detected.
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported that their evoke charger was unable to be recharged.During attempts to recharge, the patient reported that the device became warm and indicator lights illuminated.The charger was replaced to resolve the reported event.

• Brand Name: EVOKE CHARGER KIT (US)
• Common Device Name: SCS CHARGER
• 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: 23489986
• Report Number: 3021836309-2025-00301
• Device Sequence Number: 4758807
• Product Code: LGW
• UDI-Device Identifier: 09352307000063
• UDI-Public: 09352307000063
• Combination Product (Y/N): N
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 101147
• Device Catalogue Number: 3006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2024
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Female