BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 5496112 · Received March 11, 2016

    Report

    Report Number
    3007566237-2016-01365
    Event Type
    Injury
    Date Received
    March 11, 2016
    Date of Event
    November 1, 2015
    Report Date
    February 17, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE MONTH OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION (I.E. SERIAL/LOT NUMBERS) FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_UNKNOWN_EXT , PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    RADIC, J.A.E., BEAUPRIE, I., CHIASSON, P., KISS, Z.H.T., BROWNSTONE, R.M. MOTOR CORTEX STIMULATION FOR NEUROPATHIC PAIN: A RANDOMIZED CROSS-OVER TRIAL. CANADIAN JOURNAL OF NEUROLOGICAL SCIENCES. 2015;42(6):401-409. DOI: 10.1017/CJN.2015.292. SUMMARY: CHRONIC MOTOR CORTEX STIMULATION (MCS) HAS BEEN USED TO TREAT MEDICALLY REFRACTORY NEUROPATHIC PAIN OVER THE PAST 20 YEARS. WE INVESTIGATED THIS PROCEDURE USING A PROSPECTIVE MULTICENTRE RANDOMIZED BLINDED CROSSOVER TRIAL. REPORTED EVENTS: SUBJECT 3: A (B)(6) MALE PATIENT IMPLANTED WITH A MOTOR CORTEX STIMULATION (MCS) SYSTEM FOR LEFT 2ND FINGER PHANTOM LIMB PAIN EXPERIENCED A STATISTICALLY SIGNIFICANT WORSENING OF THEIR MCGILL PAIN QUESTIONNAIRE (MPQ) PAIN SCORE WHEN MOVING FROM BASELINE TO LOW STIMULATION AND IN THEIRMPQ TOTAL PAIN SCORE WHEN MOVING FROM BASELINE TO A HIGH STIMULATION STATE. THE SHORT FORM 36 QUALITY OF LIFE SCALE (SF-36) ROLE PHYSICAL SCORES IN THE HIGH STIMULATION CONDITION WERE SIGNIFICANTLY LOWER THAN IN THE LOW INTENSITY CONDITION, INDICATING A WORSENING OF ROLE PHYSICAL SCORES WHEN PATIENTS MOVED FROM LOW TO HIGH STIMULATION AND THE SF-36 MENTAL HEALTH SCORES IN THE HIGH STIMULATION CONDITION WERE SIGNIFICANTLY LOWER THAN IN THE LOW INTENSITY CONDITION, INDICATING A WORSENING OF MENTAL HEALTH SCORES WHEN PATIENTS MOVED FROM LOW TO HIGH STIMULATION. IT WAS STATED THAT THERE WAS A "CLEAR LACK OF PATIENT SATISFACTION THAT SUGGESTED THAT THE THERAPY WAS NOT EFFECTIVE." THE PATIENT FELT THEY RECEIVED NO BENEFIT FROM THE MCS SYSTEM AND EXPERIENCED TENSION ON THE EXTENSION SO THE STIMULATOR WAS EXPLANTED. IT WAS NOTED THAT PATIENTS WERE IMPLANTED WITH 3587A LEADS AND "7426A" EXTENSIONS. FOLLOW-UP TO THE ARTICLE'S CORRESPONDING AUTHOR HAS BEEN REQUESTED FOR PATIENT/DEVICE INFO, EVENT DATES, AND POTENTIAL CAUSES. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151303 ITREL 3 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7425 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention