BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 4199311 · Received October 24, 2014

    Report

    Report Number
    3007566237-2014-03102
    Event Type
    Injury
    Date Received
    October 24, 2014
    Report Date
    October 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. THE USE OF THIS DEVICE WAS OFF LABEL AS IT WAS USED FOR SUBDURAL MOTOR CORTEX STIMULATION, NOT SPINAL CORD STIMULATION. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE: EXTENSION; PRODUCT ID 3998, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    DELAVALLEE, M., FINET, P., DE TOURTCHANINOFF, M., RAFTOPOULOS, C. SUBDURAL MOTOR CORTEX STIMULATION: FEASIBILITY, EFFICACY AND SECURITY ON A SERIES OF 18 CONSECUTIVE CASES WITH A FOLLOW-UP OF AT LEAST 3 YEARS. ACTA NEUROCHIRURGICA. 2014. DOI: 10.1007/S00701-014-2240-4. SUMMARY: MOTOR CORTEX STIMULATION (MCS) IS CONSIDERED TO BE AN EFFECTIVE TREATMENT IN SOME TYPES OF CHRONIC REFRACTORY NEUROPATHIC PAIN. THE AIM OF THIS STUDY IS TO EVALUATE AND CONFIRM THE FEASIBILITY, EFFICACY AND SECURITY OF OUR SURGICAL TECHNIQUE FOR SUBDURAL MOTOR CORTEX STIMULATION (SDMCS) ON 18 CONSECUTIVE CASES WITH FOLLOW-UP OF AT LEAST 3 YEARS. OUR POPULATION CONSISTS OF 18 CONSECUTIVE PATIENTS (12 MALE) BETWEEN 2000 AND 2010,WITH A MEAN AGE OF 63 YEARS (11¿91). THE MEAN FOLLOW-UP WAS 86 MONTHS (20¿140 MONTHS). WE IDENTIFIED THE CENTRAL SULCUS BY USING CLASSICAL ANATOMIC LANDMARKS AND NEURONAVIGATION (BRAINLAB SYSTEM; BRAINLAB, INC., (B)(4)). AN ELONGATED CRANIOTOMY (3 CM IN LENGTH, 1 CM IN WIDTH)WAS PERFORMED FOLLOWED BY LINEAR OPENING OF THE DURA MATER. AN EIGHT-POLAR PLATE ELECTRODE (SPECIFY LEAD, 3998; MEDTRONIC, (B)(4)) WAS THEN SLIPPED SMOOTHLY THROUGH THIS LINEAR OPENING. IN PATIENTS WITH INTERHEMISPHERIC ELECTRODES (PATIENTS 2 AND 17), WE PERFORMED A PARASAGITTAL CRANIOTOMY OF 4 CM LENGTH AND 2 CM WIDTH. AT LAST FOLLOW-UP ASSESSMENT, 14 PATIENTS HAD A FAVOURABLE OUTCOME (77.7 %): 10 PATIENTS WITH EXCELLENT RELIEF OF PAIN (>80 %), 1 WITH GOOD RELIEF OF PAIN (60¿80 %) AND 3 WITH SATISFACTORY RELIEF OF PAIN (50¿60 %). FOUR PATIENTS SHOWED BAD RESULTS (<(><<)>50 %). WE DID NOT OBSERVE ANY LATE COMPLICATIONS SPECIFIC TO SD MCS. WE REPORT AN EFFICACY AT LEAST AS GOOD AS ED MCS, WITH NO COMPLICATIONS SPECIFIC TO SD MCS, EVEN WITH PROLONGED FOLLOW-UP. THE DATA ARE INSUFFICIENT TO ACTUALLY PROVE A LOWER ENERGY USE IN SD MCS. REPORTED EVENT: ONE (B)(6) MALE PATIENT PRESENTED SUPERFICIAL INFECTION AT THE LEVEL OF CONNECTION BETWEEN THE LEAD AND THE EXTENSION. THE INFECTION WAS TREATED BY REMOVING THE MATERIAL AND PROVIDING ANTIBIOTHERAPY FOR TWO WEEKS. THE PATIENT WAS RE-IMPLANTED AFTER THREE MONTHS. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: SPECIFY LEAD MODEL 3998 AND SYNERGY INS MODEL 7427 FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679455 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 7427 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention