BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 10530995 · Received September 14, 2020

    Report

    Report Number
    2182207-2020-00871
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Date of Event
    April 26, 2020
    Report Date
    September 14, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED ARTICLE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD. LOT#: UNKNOWN, PRODUCT TYPE: LEAD. 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, 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. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    FISHMAN, M. A., CALODNEY, A., KIM, P., SLEZAK, J., BENYAMIN, R., REHMAN, A., SOTO, E., YANG, T., HACOBIAN, A., GRIFFITH, L., YU, C., VALLEJO, R. PROSPECTIVE, MULTICENTER FEASIBILITY STUDY TO EVALUATE DIFFERENTIAL TARGET MULTIPLEXED SPINAL CORD STIMULATION PROGRAMMING IN SUBJECTS WITH CHRONIC INTRACTABLE BACK PAIN WITH OR WITHOUT LEG PAIN. PAIN PRACT. 2020. DOI: 10.1111/PAPR.12908 SUMMARY: THIS PROSPECTIVE, OPEN-LABEL, MULTICENTER STUDY EVALUATEDTHEFEASIBILITYOF SPINAL CORDSTIMULATION(SCS) THERAPY PROGRAMMING FOR CHRONIC LOW BACK PAIN THAT USES MULTIPLE ELECTRICAL PULSED SIGNALS (DIFFERENTIAL TARGETMULTIPLEXED).TWENTY-FIVE SCS CANDIDATES WITH LOW BACK PAIN EQUAL TO OR GREATER THAN LOWER LIMB PAIN WERE ENROLLED AT 7 SITES IN THE UNITED STATES. THE SUBJECTS EVALUATED STANDARD AND DIFFERENTIAL TARGET MULTIPLEXED PROGRAMS, EACH FOR 4 _ 1 DAYS. A COMMERCIALLY AVAILABLE SCS TRIAL SYSTEM WAS USED FOR STANDARD SCS THERAPY PROGRAMMING. DURING THE TRIALING OF THE MULTIPLEXED PROGRAMS, IMPLANTED TEMPORARY LEADS WERE CONNECTED TO AN INVESTIGATIONAL EXTERNAL TRIAL STIMULATOR SYSTEM. TWENTY SUBJECTS CONCLUDED THE STUDY. THE MEAN BASELINE NUMERIC PAIN RATING SCALE (NPRS) SCORE FOR LOW BACK PAIN WAS 7.4, WITH A MEAN AGE OF 62.4 YEARS AND MEAN PAIN DURATION OF 18.0 YEARS. SIGNIFICANT RELIEF IN BACK PAIN WAS OBSERVED FOR BOTH TREATMENTS, WITH SIGNIFICANTLY BETTER RESPONSE WITH MULTIPLEXED PROGRAMMING. AT THE END OF THE TRIAL PERIOD, SUBJECTS REPORTED A REDUCTION IN THEIR MEAN NPRS SCORE FROM BASELINE TO 4.2 AFTER STANDARD PROGRAMMING AND TO 2.4 AFTER DIFFERENTIAL TARGET MULTIPLEXED PROGRAMMING. THE DIFFERENCE BETWEEN STANDARD AND MULTIPLEXED PROGRAMMING WAS SIGNIFICANT. THE RESPONDER RATE FOR LOW BACK PAIN RELIEF WAS 50% FOR STANDARD PROGRAMMING AND 80% FOR DIFFERENTIAL TARGET MULTIPLEXED PROGRAMMING. EIGHTY-FIVE PERCENT OF SUBJECTS WHO EVALUATED BOTH PROGRAMMING APPROACHES PREFERRED DIFFERENTIAL TARGET MULTIPLEXED SCS. IN THIS DIFFICULT-TO-TREAT PATIENT POPULATION, SUBJECTS REPORTED SIGNIFICANT REDUCTION IN CHRONIC BACK PAIN WHEN USING MULTIPLEXED PROGRAMMING. A RANDOMIZED CLINICAL TRIAL IS NEEDED TO CONFIRM THE RESULTS FROM THIS FEASIBILITY STUDY. REPORTED EVENTS: 5 PATIENTS EXPERIENCED A LEAD MIGRATION. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993708 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1