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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE CLOSED LOOP STIMULATOR (CLS) (US); SCS IPG
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SALUDA MEDICAL PTY LTD EVOKE CLOSED LOOP STIMULATOR (CLS) (US); SCS IPG Back to Search Results
Model Number 101144
Medical Device Problem Code Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code Undesired Nerve Stimulation (1980)
Date of Event 05/15/2026
Type of Reportable Event Serious Injury
Event or Problem Description
During a magnetic resonance imaging (mri), a patient implanted with an evoke spinal cord stimulation (scs) system reported unintended stimulation.The mri was subsequently aborted.Pre-mri guidelines and device checks were reported to have been completed prior to the scan.A revision procedure was performed, and the evoke closed loop stimulator (cls) was replaced to resolve the reported event.
 
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Brand Name
EVOKE CLOSED LOOP STIMULATOR (CLS) (US)
Common Device Name
SCS IPG
Manufacturer (Section D)
SALUDA MEDICAL PTY LTD
5 eden park drive
macquarie park, nsw, 2113
AS  2113
MDR Report Key25460369
Report Number3016111136-2026-00123
Device Sequence Number8725722
Product Code LGW
UDI-Device Identifier09352307001565
UDI-Public09352307001565
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
Device Explanted 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) 05/15/2026
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 Number101144
Device Catalogue Number3002
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/15/2026
Event Location Hospital
Date Report to Manufacturer05/15/2026
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 SexFemale
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