Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE CAP12 TRIAL PERCUTANEOUS LEAD KIT - 60CM (US); SCS LEAD
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SALUDA MEDICAL PTY LTD EVOKE CAP12 TRIAL PERCUTANEOUS LEAD KIT - 60CM (US); SCS LEAD Back to Search Results
Model Number 102880
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Abdominal Pain (1685); Pain (1994); Paresis (1998); Embolism/Embolus (4438)
Date of Event 12/25/2025
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Both leads used in the procedure were from the same lot.
 
Event or Problem Description
Three (3) days after removal of the evoke scs trial leads, the patient was evaluated in a hospital setting for increased back and abdominal pain and paresis in lower limbs.A spinal blood clot was treated with surgical intervention.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EVOKE CAP12 TRIAL 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
AU  2113
MDR Report Key24111924
Report Number3016111136-2026-00010
Device Sequence Number21418432
Product Code LGW
UDI-Device Identifier09352307000797
UDI-Public09352307000797
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2025
Device Explanted Year2025
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/19/2026
Report Date (Section F) 12/25/2025
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 Number102880
Device Catalogue Number3016
Device Lot Number9018271353
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/25/2025
Event Location Hospital
Date Report to Manufacturer12/25/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/19/2026
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device A
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Other;
Patient SexFemale
-
-