BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 10334090 · Received July 28, 2020

    Report

    Report Number
    2182207-2020-00593
    Event Type
    Injury
    Date Received
    July 28, 2020
    Date of Event
    February 11, 2020
    Report Date
    July 28, 2020
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. 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. PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. 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.,MENS, M. THE LONG-TERM RESPONSE TO HIGH-DOSE SPINAL CORD STIMULATION IN PATIENTS WITH FAILED BACK SURGERY SYNDROME AFTER CONVERSION FROM STANDARD SPINAL CORD STIMULATION: AN EFFECTIVENESS AND PREDICTION STUDY. NEUROMODULATION. 2020. DOI: 10.1111/NER.13138 SUMMARY: SPINAL CORD STIMULATION (SCS) IS NOWADAYS AVAILABLE WITH SEVERAL STIMULATION P.ARADIGMS. 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 DEVELOP A MODEL FOR PREDICTION OF LONG-TERM RESPONSE OF HD-SCS 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 (NRS DECREASE =2/10) AFTER 12 MONTHS OF HD-SCS. SIGNIFICANT TIME EFFECTS WERE FOUND FOR BOTH LOW BACK AND LEG PAIN RESPONDERS, SUGGESTING THE EFFECTIVENESS OF HDSCS AFTER CONVERSION. LOGISTIC REGRESSION MODELS REVEALED THE IMPORTANCE OF PAIN INTENSITY SCORES, MEDICATION USE, PARESTHESIA COVERAGE (FOR BACK PAIN) AND EQ5D (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 HD-SCS IN PATIENTS WITH FBSS EXPERIENCING INADEQUATE RESPONSE TO STANDARD SCS. REPORTED EVENTS: 1. ONE PATIENT EXPERIENCED AN INFECTION AND WAS LOST TO FOLLOW UP PRIOR TO THEIR 3 MONTH FOLLOW UP. 2. ONE PATIENT EXPERIENCED A REVISION AND WAS LOST TO FOLLOW UP PRIOR TO THEIR 3 MONTH FOLLOW UP. 3. ONE PATIENT EXPERIENCED A REVISION AND WAS LOST TO FOLLOW UP PRIOR TO THEIR 12 MONTH FOLLOW UP. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798483 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention