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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE CAP12 PERCUTANEOUS LEAD KIT - 90CM (US); SCS LEAD
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SALUDA MEDICAL PTY LTD EVOKE CAP12 PERCUTANEOUS LEAD KIT - 90CM (US); SCS LEAD Back to Search Results
Model Number 102879
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 10/15/2025
Type of Reportable Event Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system was evaluated for an infection at the evoke cap12 percutaneous lead implant site.Topical solution and antibiotics were prescribed to treat the infection.
 
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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
MDR Report Key23521891
Report Number3016111136-2025-00195
Device Sequence Number18630737
Product Code LGW
UDI-Device Identifier09352307001657
UDI-Public09352307001657
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2025
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/11/2025
Report Date (Section F) 10/15/2025
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 Model Number102879
Device Catalogue Number3009
Device Lot Number9018338852
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/15/2025
Event Location Hospital
Date Report to Manufacturer10/15/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/11/2025
Date Device Manufactured11/21/2024
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 Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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