BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE SCS SYSTEM

    MDR report key: 17906349 · Received October 10, 2023

    Report

    Report Number
    3021836309-2023-00140
    Event Type
    Injury
    Date Received
    October 10, 2023
    Date of Event
    September 10, 2023
    Report Date
    November 20, 2023
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    UDI-DI
    09352307000797
    PMA / PMN Number
    P190002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LEAD AND ECLS WERE RETURNED TO SALUDA FOR ANALYSIS. THE LEAD HAD A SUTURE TIED DIRECTLY TO THE MIDSECTION. THE MANUFACTURER'S INSTRUCTIONS FOR USE (IFU) ADVISES NOT TO SUTURE DIRECTLY TO THE LEAD AS IT MAY DAMAGE THE LEAD OR CAUSE IT TO FAIL. BOTH THE LEAD AND ECLS PASSED ALL TESTING AND NO OTHER OBVIOUS DAMAGE WAS NOTED. THE PATIENT LOGS WERE REVIEWED WHICH CONFIRMED THE REPORT THAT THE PATIENT¿S CLOSED LOOP NOT TRACKING WELL. THE PATIENT WAS ADVISED TO USE THEIR OPEN-LOOP PROGRAM INSTEAD OF THE CLOSED-LOOP PROGRAM, BUT THE LOGS DEMONSTRATE THAT THE PATIENT CONTINUED TO USE CLOSED-LOOP PROGRAMS UNTIL THE TIME OF THE EVENT. THE STOP BUTTON ON THE EPC WAS PRESSED WITHIN A MINUTE OF THE EVENT. THE LOGS INDICATE THAT THE CURRENT SUPPLIED BY THE DEVICE WAS IN THE RANGE USUAL FOR THE PATIENT THE DAY OF THE EVENT, AND NO ERRORS WERE NOTED IN THE HOUR BEFORE THE REPORTED EVENT. NO EVENT OR DATA IN THE PATIENT LOGS COULD BE DETERMINED TO BE AN INDICATION OF ABNORMAL STIMULATION AT THE TIME THE EVENT WAS REPORTED. THE CAUSE OF THE EVENT AS REPORTED COULD NOT BE CONFIRMED. THE MANUFACTURING RECORDS WERE REVIEWED. THE PRODUCT MET ALL REQUIREMENTS FOR RELEASE WITH NO ANOMALIES IDENTIFIED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THREE DAYS AFTER THE PATIENT WAS IMPLANTED WITH AN EVOKE TRIAL PERCUTANEOUS LEAD KIT - 60CM, USED WITH AN EVOKE EXTERNAL CLOSED LOOP STIMULATOR (ECLS), THE PATIENT RECEIVED A SUDDEN INCREASE IN STIMULATION AND REPORTED BEING UNABLE TO MOVE THEIR LEGS. THE PHYSICIAN REMOVED THE TRIAL LEAD AND REPORTED THE PATIENT HAD SENSATION IN THEIR LEGS. A MAGNETIC RESONANCE IMAGING WAS PERFORMED WHICH REVEALED NO ABNORMALITIES. THE PATIENT HAS SINCE REGAINED FULL MOVEMENT IN THEIR LEGS AND IS ABLE TO WALK INDEPENDENTLY.

    Description of Event or Problem · 0

    THREE DAYS AFTER THE PATIENT WAS IMPLANTED WITH AN EVOKE TRIAL PERCUTANEOUS LEAD KIT - 60CM, USED WITH AN EVOKE EXTERNAL CLOSED LOOP STIMULATOR (ECLS), THE PATIENT RECEIVED A SUDDEN INCREASE IN STIMULATION AND REPORTED BEING UNABLE TO MOVE THEIR LEGS. THE PHYSICIAN REMOVED THE TRIAL LEAD AND REPORTED THE PATIENT HAD SENSATION IN THEIR LEGS. A MAGNETIC RESONANCE IMAGING WAS PERFORMED WHICH REVEALED NO ABNORMALITIES. THE PATIENT HAS SINCE REGAINED FULL MOVEMENT IN THEIR LEGS AND IS ABLE TO WALK INDEPENDENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283262 EVOKE SCS SYSTEM SCS LEAD LGW SALUDA MEDICAL PTY LTD EVOKE CAP12 TRIAL PERCUTANEOUS LEAD KIT - 60CM 09352307000797

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other