BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 10531032 · Received September 14, 2020

    Report

    Report Number
    2182207-2020-00872
    Event Type
    Injury
    Date Received
    September 14, 2020
    Date of Event
    April 26, 2020
    Report Date
    November 10, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H2: PLEASE NOTE THAT CONCLUSION CODE 67 HAS BEEN REPLACED WITH CONCLUSION CODE 22 AT THIS TIME. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 EVALUATED THE FEASIBILITY OF SPINAL CORD STIMULATION(SCS) THERAPY PROGRAMMING FOR CHRONIC LOW BACK PAIN THAT USES MULTIPLE ELECTRICAL PULSED SIGNALS (DIFFERENTIAL TARGET MULTIPLEXED).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 TRAILING 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: ONE PATIENT EXPERIENCED AN EPIDURAL ABSCESS DUE TO AN INFECTION (SERIOUS ADVERSE EVENT). THIS SUBJECT UNDERWENT ANTIBIOTIC TREATMENT AND FULLY RECOVERED WITH NO LONG-TERM SEQUELAE. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995320 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other