BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 7777114 · Received August 13, 2018

    Report

    Report Number
    3007566237-2018-02399
    Event Type
    Injury
    Date Received
    August 13, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE: EXTENSION, PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998 PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_EXT PRODUCT TYPE EXTENSION. 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 A (B)(6) YEAR-OLD MALE PATIENT (PATIENT 1) EXPERIENCED AN INFECTION OF THE ELECTRODE AND THE EXTENSION WIRE. THE ELECTRODES WERE REMOVED. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617398 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 50 YR Required Intervention