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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 - 60CM; SCS LEAD
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SALUDA MEDICAL PTY LTD EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM; SCS LEAD Back to Search Results
Model Number 102878
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Wound Dehiscence (1154); Necrosis (1971); Impaired Healing (2378)
Date of Event 05/11/2026
Type of Reportable Event Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system was evaluated for delayed healing and signs of dehiscence at the midline incision site.Washout and debridement were performed, and antibiotics were administered at the midline incision site.
 
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Brand Name
EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM
Common Device Name
SCS LEAD
Manufacturer (Section D)
SALUDA MEDICAL PTY LTD
5 eden park drive
macquarie park, nsw 2113
AS  2113
MDR Report Key25461540
Report Number3016111136-2026-00121
Device Sequence Number15634811
Product Code LGW
UDI-Device Identifier09352307001640
UDI-Public09352307001640
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2026
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/10/2026
Report Date (Section F) 05/11/2026
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 Model Number102878
Device Catalogue Number3008
Device Lot Number9018427736
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/11/2026
Event Location Hospital
Date Report to Manufacturer05/11/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/10/2026
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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