MAUDE Adverse Event Report: Saluda Medical PTY LTD Evoke CAP12 Percutaneous Lead Kit - 60cm (US); SCS LEAD

Model Number	102878
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Incontinence (1928); Unspecified Infection (1930); Muscle Weakness/Atrophy (1967); Ambulation or Postural Difficulties (2544)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system was evaluated in the emergency department for weakness, disorientation, mild fever and bladder issues.Anomalies were not identified via computed tomography (ct) scan and blood tests.Redness or drainage were not observed at the lead implant site.The patient was hospitalized and antibiotics were administered as a precautionary measure.An infection was detected during an ultrasound scan and the evoke scs system was subsequently explanted.The physician indicated that the event may have been triggered by the patient¿s fall and patient¿s poor hygiene may have contributed to the infection.
Additional Manufacturer Narrative
Investigation of this event is in progress.Once the investigation is complete, a supplemental report will be submitted.
Additional Manufacturer Narrative
(b)(4).Additional information: section d - expiration date; unique identifier (udi).Section g - date received by manufacturer; type of report.Section h - device manufacture date; evaluation codes.The evoke scs system was not returned to saluda.The root cause of the infection could not be definitively determined; however, the physician noted the infection could be related to poor hygiene.The evoke scs system surgical guide details potential risks associated with surgery and spinal cord stimulation including, "infection that may require hospitalization with intravenous antibiotic therapy" and continues by stating, "the patient may require surgery (including revision, explant, and replacement)" as a result of these risks.The manufacturing records were reviewed and the products met all the requirements for release.

• Brand Name: Evoke CAP12 Percutaneous Lead Kit - 60cm (US)
• 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: 50225025
• Report Number: 3021836309-2026-00235
• Device Sequence Number: 10273479
• Product Code: SCS
• UDI-Device Identifier: 09352307001640
• UDI-Public: 09352307001640
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 09/30/2026

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: 10/02/2026
• Device Model Number: 102878
• Device Catalogue Number: 3008
• Device Lot Number: 9018090591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2024
• 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; Hospitalization
• Patient Sex: Male