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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 EVOKE ACTIVE ANCHOR KIT (US)
Medical Device Problem Codes Inappropriate/Inadequate Shock/Stimulation (1574); Migration (4003)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 07/19/2024
Type of Reportable Event Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported a change in therapy coverage.An x-ray was obtained which revealed migration of both leads.The evoke scs system was explanted.
 
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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
AS  2113
MDR Report Key20286034
Report Number3016111136-2024-00205
Device Sequence Number12734078
Product Code LGW
UDI-Device Identifier09352307000810
UDI-Public09352307000810
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 Year2024
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/23/2024
Report Date (Section F) 09/03/2024
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 Date05/01/2025
Device Model NumberEVOKE ACTIVE ANCHOR KIT (US)
Device Catalogue Number3043
Device Lot Number9015520003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/03/2024
Event Location Hospital
Date Report to Manufacturer09/03/2024
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/23/2024
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 Other;
Patient SexFemale
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