BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3489725 · Received November 26, 2013

    Report

    Report Number
    3007566237-2013-03850
    Event Type
    Injury
    Date Received
    November 26, 2013
    Report Date
    October 31, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_EXT, LOT # UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_ UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    MARTINEZ, J., VIDARTE, O., URIBE, G. FUNCTIONAL NEUROSURGERY FOR SECONDARY DYSTONIA: INDICATIONS AND LONG-TERM RESULTS. IN: NIKKHAH G, PINSKER M, EDS. STEREOTACTIC AND FUNCTIONAL NEUROSURGERY. VOL 117: SPRINGER VIENNA; 2013:61-66. SUMMARY: DYSTONIA IS A MOVEMENT DISORDER CHARACTERIZED BY PATTERNED, REPETITIVE, PHASIC, OR TONIC SUSTAINED MUSCLE CONTRACTIONS THAT PRODUCE ABNORMAL, OFTEN TWISTING, POSTURES OR REPETITIVE MOVEMENTS. WHEN THE DISORDER IS GENETIC OR THE CAUSE IS UNKNOWN AND DYSTONIA IS THE SOLE FEATURE, THE DISEASE IS CALLED PRIMARY OR IDIOPATHIC, CONVERSELY SECONDARY DYSTONIA (SD) MAY BE CAUSED BY VARIOUS BRAIN INSULTS. BOTH PRIMARY DYSTONIA AND SD HAVE BEEN NOTORIOUS FOR THEIR POOR RESPONSE TO MEDICAL TREATMENT. TODAY, STEREOTACTIC NEUROSURGICAL PROCEDURES ARE OFFERED TO IMPROVE THE DISABILITY AND QUALITY OF LIFE OF PATIENTS WHO DO NOT RESPOND TO MEDICAL THERAPY. HOWEVER, SD SHOWS LESS AND MORE VARIABLE RESULTS THAN PRIMARY DYSTONIA TO NEUROSURGICAL PROCEDURES, THE BENEFITS OF ABLATIVE OR DEEP BRAIN STIMULATION (DBS) PROCEDURES IN BASAL STRUCTURES BEING STILL SUBJECT TO DEBATE AND MUCH HARDER TO FULLY APPRECIATE. IN THIS WORK, THE AUTHORS SHOW A 33-PATIENT SERIES WITH SECONDARY DYSTONIA, SEPARATING THE STATISTIC AND CLINICAL ANALYSIS INTO SEVERAL ETIOLOGY GROUPS: PERINATAL INSULTS, TARDIVE SYNDROMES, GENETIC SYNDROMES, AND POSTTRAUMATIC. IN THESE GROUPS, WE SHOW THE MEAN BFM SCORE IMPROVEMENT IN THE DIFFERENT PATIENT SERIES, COMPARING OUR RESULTS WITH WORLD LITERATURE, AND FINALLY PROPOSE A CLASSIFICATION SYSTEM FOR BETTERING THE CLINICAL APPROACH IN SURGERY DECISION WHEN THIS IS INDICATED. REPORTED EVENT: ONE (B)(6) PATIENT WITH SECONDARY DYSTONIA DUE TO TARDIVE SYNDROMES HAD A SURGICAL REVISION DUE TO BREAKAGE OF THE EXTENSION CABLES ONE MONTH AFTER SURGERY. IT WAS NOTED THAT THE CAUSE WAS VIOLENT MOVEMENTS THAT SUBJECTED THE CABLES TO SHEARING FORCES. 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
    615554 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention