BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 9166582 · Received October 8, 2019

    Report

    Report Number
    3007566237-2019-02086
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    July 16, 2019
    Report Date
    October 8, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DE JAEGER, M., GOUDMAN, L., BROUNS, R., DE SMEDT, A., LINDEROTH, B., ELDABE, S., MOENS, M. THE LONG-TERM RESPONSE OF HIGH DOSE SPINAL CORD STIMULATION IN PATIENTS WITH FAILED BACK SURGERY SYNDROME AFTER CONVERSION FROM STANDARD SPINAL CORD STIMULATION: AN EFFECTIVENESS AND PREDICTION STUDY. 2019. SUMMARY: SPINAL CORD STIMULATION (SCS) IS NOWADAYS AVAILABLE WITH SEVERAL STIMULATION PARADIGMS. NEW PARADIGMS, SUCH AS HIGH DOSE (H D-)SCS, HAVE SHOWN THE POSSIBILITY TO SALVAGE PATIENTS WHO LOST THEIR INITIAL PAIN RELIEF. THE FIRST AIM OF THIS STUDY IS TO EVALUATE THE EFFECTIVENESS OF HD-SCS AFTER CONVERSION FROM STANDARD SCS. THE SECOND AIM IS TO DEVELOPA MODEL FOR PREDICTION OF LONG-TERM RESPONSE OF HDSCS AFTER UNSATISFACTORY STANDARD SCS. SEVENTY-EIGHT PATIENTS WITH FAILED BACK SURGERY SYNDROME (FBSS) WHO ARE TREATED WITH STANDARD SCS WERE ENROLLED IN THE STUDY. SELF-REPORTING QUESTIONNAIRES AND OUTCOMES WERE ASSESSED BEFORE CONVERSION AND AT 1, 3 AND 12 MONTHS OF HD-SCS. LONGITUDINAL MIXED MODELS WERE USED TO DETERMINE THE EFFECTIVENESS OF HD-SCS. LOGISTIC REGRESSION AND CLASSIFICATION AND DECISION TREE ANALYSES WERE PERFORMED TO PREDICT RESPONDERS (>30% PAIN RELIEF) AFTER 12 MONTHS OF HD-SCS. SIGNIFICANT TIME EFFECTS WERE FOUND FOR LOW BACK PAIN RESPONDERS (WALD TEST F=11.43, P=0.0009) AND LEG PAIN RESPONDERS (WALD TEST F=9.43, P=0.0025). LOGISTIC REGRESSION MODELS REVEALED THE IMPORTANCE OF PAIN INTENSITY SCORES, MEDICATION USE, DISABILITY AND SLEEP QUALITY (THE LATTER ONLY FOR LEG PAIN) AS PREDICTORS FOR BEING A RESPONDER AFTER 12 MONTHS OF HD-SCS. CONVERTING PATIENTS WITH UNSATISFACTORY RESPONSES FROM STANDARD SCS TO HD-SCS MAY BE AN EFFECTIVE STRATEGY TO OBTAIN AND MAINTAIN PAIN RELIEF IN A CHALLENGING SUBGROUP OF PATIENTS WITH FBSS REFRACTORY TO STANDARD SCS. THE PREDICTION MODELS MAY GUIDE CLINICIANS IN THEIR DECISION MAKING WHEN CONSIDERING CONVERSION TO HDSCS IN PATIENTS WITH FBSS EXPERIENCING INADEQUATE RESPONSE TO STANDARD SCS. REPORTED EVENTS: 19 PATIENTS WERE LOST TO FOLLOW UP DUE TO PROBLEMS WITH THE BATTERY, TERMINATION OF SCS TREATMENT OR UNKNOWN REASONS. FOR THOSE 19 PATIENTS, THE LAST OBSERVATION CARRIED FORWARD METHOD WAS APPLIED. THIS APPROACH RESULTED IN 9 RESPONDERS FOR LOW BACK PAIN AND 12 RESPONDERS FOR LEG PAIN. SEE ATTACHED LITERATURE ARTICLE. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963340 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1