BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 7782462 · Received August 14, 2018

    Report

    Report Number
    3007566237-2018-02421
    Event Type
    Injury
    Date Received
    August 14, 2018
    Date of Event
    January 30, 2018
    Report Date
    November 8, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    HENSSEN, D., KURT, E., VAN CAPPELLEN VAN WALSUM A. M., ARNTS, I., DOORDUIN, J., KOZICZ, T., VAN DONGEN, R., RONALD, H. M., BARTELS, A. LONG-TERM EFFECT OF MOTOR CORTEX STIMULATION IN PATIENTS SUFFERING FROM CHRONIC NEUROPATHIC PAIN: AN OBSERVATIONAL STUDY. PLOS ONE. 2018. 13(1): E0191774. DOI: 10.1371/JOURNAL.PONE.0191774 SUMMARY: MOTOR CORTEX STIMULATION (MCS) WAS INTRODUCED AS A LAST-RESORT TREATMENT FOR CHRONIC NEUROPATHIC PAIN. OVER THE YEARS, MCS HAS BEEN USED FOR THE TREATMENT OF VARIOUS PAIN SYNDROMES BUT LONG-TERM FOLLOW-UP IS UNKNOWN. THIS PAPER REPORTS THE RESULTS OF MCS FROM 2005 UNTIL 2012 WITH A 3-YEAR FOLLOW-UP. PATIENTS WHO SUFFERED FROM CHRONIC NEUROPATHIC PAIN TREATED WITH MCS WERE STUDIED. THE ANALGESIC EFFECT WAS DETERMINED AS SUCCESSFUL BY DECREASE IN PAIN-INTENSITY ON THE VISUAL ANALOG SCALE (VAS) OF AT LEAST 40%. THE MODIFICATIONS IN DRUG REGIMENS WERE MONITORED WITH USE OF THE MEDICATION QUANTIFICATION SCALE (MQS). STIMULATION PARAMETERS AND COMPLICATIONS WERE ALSO NOTED. INTERFERENCE OF PAIN WITH QUALITY OF LIFE (QOL), THE QUALITY OF LIFE INDEX (QLI), WAS DETERMINED WITH USE OF A SPECIFIC SUBSET OF QUESTIONS FROM THE MPQ-DLV SCORE. EIGHTEEN PATIENTS WERE INCLUDED. MEAN PRE-OPERATIVE VAS CHANGED FROM 89. 4 ± 11.2 TO 53.1 ± 25.0 AFTER THREE YEARS OF FOLLOW-UP (P <(><<)> 0.0001). A SUCCESSFUL OUTCOME WAS ACHIEVED IN SEVEN RESPONDERS (38.9%). ALL PATIENTS IN THE RESPONDER GROUP SUFFERED FROM PAIN CAUSED BY A CENTRAL LESION. WITH REGARD TO ALL THE PATIENTS WITH CENTRAL PAIN LESIONS (N = 10) AND PERIPHERAL LESIONS (N = 8), A SIGNIFICANT DIFFERENCE IN RESPONSE TO MCS WAS NOTICED (P = 0.002). MQS SCORES AND QLI-SCORES DIMINISHED DURING THE FOLLOW-UP PERIOD (P = 0.210 AND P =0.007, RESPECTIVELY). MCS SEEMS A PROMISING THERAPEUTIC OPTION FOR PATIENTS WITH REFRACTORY PAIN SYNDROMES OF CENTRAL ORIGIN. REPORTED EVENTS: (B)(6) FEMALE PATIENT (PATIENT 16) HAD THEIR DEVICE REMOVED DUE OF MINIMAL EFFECT ACCORDING TO PATIENT¿S PERSPECTIVE. THE PATIENT¿S PAIN RELIEF WAS UNSATISFACTORY. NO SPECIFIC DEVICE INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT NONE OF THE MENTIONED ADVERSE EVENTS (E.G., TEMPORARY SEIZURE, INFECTION) WERE RELATED DIRECTLY TO MEDTRONIC DEVICES OR PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623237 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 61 YR Required Intervention