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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE SCS SYSTEM; SCS ANCHOR
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SALUDA MEDICAL PTY LTD EVOKE SCS SYSTEM; SCS ANCHOR Back to Search Results
Model Number 102996
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/04/2025
Type of Reportable Event Serious Injury
Event or Problem Description
A patient with an evoke spinal cord stimulation (scs) system was evaluated for a change in stimulation.A lead migration was confirmed.The patient reported a fall prior to the reported event.The evoke scs system did not cause or contribute to the patient¿s falls.A lead revision was completed and therapy restored.
 
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Brand Name
EVOKE SCS SYSTEM
Common Device Name
SCS ANCHOR
Manufacturer (Section D)
SALUDA MEDICAL PTY LTD
5 eden park drive
macquarie park, nsw 2113
AU  2113
MDR Report Key21469445
Report Number3016111136-2025-00024
Device Sequence Number11675720
Product Code LGW
UDI-Device Identifier09352307001718
UDI-Public09352307001718
Combination Product (Y/N)N
Initial Reporter StateKS
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/26/2025
Report Date (Section F) 02/04/2025
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 Expiration Date12/08/2024
Device Model Number102996
Device Catalogue Number3043
Device Lot Number9014702810
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Date Report to Manufacturer02/04/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date02/26/2025
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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