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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE SCS SYSTEM; SCS LEAD
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SALUDA MEDICAL PTY LTD EVOKE SCS SYSTEM; SCS LEAD Back to Search Results
Model Number EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 12/13/2023
Type of Reportable Event Serious Injury
Event or Problem Description
A patient implanted with an evoke spinal cord stimulation (scs) system reported no longer receiving pain coverage.It was identified that the implanted leads had migrated.The scs system was replaced during a revision procedure.The impedances post procedure were within acceptable range.
 
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Brand Name
EVOKE SCS SYSTEM
Common Device Name
SCS LEAD
Manufacturer (Section D)
SALUDA MEDICAL PTY LTD
5 eden park drive
macquarie park, nsw 2113
AS  2113
MDR Report Key18450176
Report Number3016111136-2024-00140
Device Sequence Number7092265
Product Code LGW
UDI-Device Identifier09352307000773
UDI-Public09352307000773
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2023
Serviced by Third Party (Y/N)N
Reporter Type Importer
Report Source Health Professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/04/2024
Report Date (Section F) 12/13/2023
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 NumberEVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM
Device Catalogue Number3008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/13/2023
Event Location Hospital
Date Report to Manufacturer12/13/2023
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/05/2024
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
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 A
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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