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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE SCS SYSTEM; SCS ACTIVE ANCHOR
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SALUDA MEDICAL PTY LTD EVOKE SCS SYSTEM; SCS ACTIVE ANCHOR Back to Search Results
Model Number EVOKE ACTIVE ANCHOR KIT (US)
Medical Device Problem Codes Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Health Effect - Clinical Code Impaired Healing (2378)
Date of Event 05/31/2024
Type of Reportable Event Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system was explanted due to a lead migration and wound breakdown.
 
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Brand Name
EVOKE SCS SYSTEM
Common Device Name
SCS ACTIVE ANCHOR
Manufacturer (Section D)
SALUDA MEDICAL PTY LTD
5 eden park drive
macquarie park, nsw 2113
AS  2113
MDR Report Key20129067
Report Number3016111136-2024-00204
Device Sequence Number7398688
Product Code LGW
UDI-Device Identifier09352307000810
UDI-Public09352307000810
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2023
Device Explanted Year2024
Serviced by Third Party (Y/N)N
Reporter Type Importer
Report Source Health Professional,Company Representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/03/2024
Report Date (Section F) 05/31/2024
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 Lay User/Patient
Device Model NumberEVOKE ACTIVE ANCHOR KIT (US)
Device Catalogue Number3043
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/31/2024
Event Location Hospital
Date Report to Manufacturer05/31/2024
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/03/2024
Is the Device Labeled for Single Use? (Y/N) Yes
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 SexMale
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