BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 7895668 · Received September 20, 2018

    Report

    Report Number
    3007566237-2018-02827
    Event Type
    Injury
    Date Received
    September 20, 2018
    Date of Event
    December 5, 2017
    Report Date
    September 20, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#:. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    POMMIER, B., QUESADA, C., FAUCHON, C., NUTI, C., VASSAL, F., PEYRON, R. ADDED VALUE OF MULTIPLE VERSUS SINGLE SESSIONS OF REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION IN PREDICTING MOTOR CORTEX STIMULATION EFFICACY FOR REFRACTORY NEUROPATHIC PAIN. J NEUROSURG. 2018. 1-12. DOI: ABS/10.3171/2017.12.JNS171333. SUMMARY: SELECTION CRITERIA FOR OFFERING PATIENTS MOTOR CORTEX STIMULATION (MCS) FOR REFRACTORY NEUROPATHIC PAIN ARE A CRITICAL TOPIC OF RESEARCH. A SINGLE SESSION OF REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION (RTMS) HAS BEEN ADVOCATED FOR SELECTING MCS CANDIDATES, BUT IT HAS A LOW NEGATIVE PREDICTIVE VALUE. HERE THE AUTHORS INVESTIGATED WHETHER MULTIPLE RTMS SESSIONS WOULD MORE ACCURATELY PREDICT MCS EFFICACY. PATIENTS INCLUDED IN THIS LONGITUDINAL STUDY COULD ACCESS MCS AFTER AT LEAST FOUR RTMS SESSIONS PERFORMED 3¿4 WEEKS APART. THE POSITIVE (PPV) AND NEGATIVE (NPV) PREDICTIVE VALUES OF THE FOUR RTMS SESSIONS AND THE CORRELATION BETWEEN THE ANALGESIC EFFECTS OF THE TWO TREATMENTS WERE ASSESSED. TWELVE MCS PATIENTS UNDERWENT AN AVERAGE OF 15.9 RTMS SESSIONS PRIOR TO SURGERY; NINE OF THE PATIENTS WERE RTMS RESPONDERS. POSTOPERATIVE FOLLOW-UP WAS 57.8 ± 15.6 MONTHS (MEAN ± STANDARD DEVIATION). MEAN PERCENTAGE OF PAIN RELIEF (%R) WAS 21% AND 40% AFTER THE FIRST AND FOURTH RTMS SESSIONS, RESPECTIVELY. THE CORRESPONDING MEAN DURATIONS OF PAIN RELIEF WERE RESPECTIVELY 2.4 AND 12.9 DAYS. A CUMULATIVE EFFECT OF THE RTMS SESSIONS WAS OBSERVED ON BOTH %R AND DURATION OF PAIN RELIEF (P < 0.01). THE %R VALUE OBTAINED WITH MCS WAS 35% AFTER 6 MONTHS AND 43% AT THE LAST FOLLOW-UP. BOTH THE PPV AND NPV OF RTMS WERE 100% AFTER THE FOURTH RTMS SESSION (P = 0.0045). A SIGNIFICANT CORRELATION WAS FOUND BETWEEN %R OR DURATION OF PAIN RELIEF AFTER THE FOURTH RTMS SESSION AND %R AT THE LAST MCS FOLLOW-UP (R2 = 0.83, P = 0.0003).FOUR RTMS SESSIONS PREDICTED MCS EFFICACY BETTER THAN A SINGLE SESSION IN NEUROPATHIC PAIN PATIENTS. TAKING INTO ACCOUNT THE CUMULATIVE EFFECTS OF RTMS, THE AUTHORS FOUND A HIGH-LEVEL CORRELATION BETWEEN THE ANALGESIC EFFECTS OF RTMS AND MCS. REPORTED EVENTS: POSTOPERATIVE ADVERSE SIDE EFFECTS WERE OBSERVED IN FOUR PATIENTS (33%): TWO PATIENTS (17%) PRESENTED WITH HARDWARE INFECTION REQUIRING COMPLETE REMOVAL OF THE NEUROMODULATION DEVICES. ONE PATIENT (8%) PRESENTED WITH AN ASEPTIC WOUND DEHISCENCE REQUIRING REMOVAL OF THE NEUROSTIMULATOR ALONE. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734561 NEU_INS_STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R