BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 12340446 · Received August 18, 2021

    Report

    Report Number
    2182207-2021-01437
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    April 20, 2021
    Report Date
    August 18, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVIDENTE VGH, ROKHLIN P, EVIDENTE MH, LAMBERT M, GARRETT R, PONCE FA. THALAMIC DEEP BRAIN STIMULATION IS EFFECTIVE IN ALLEVIATING CR ANIOCERVICAL DYSTONIA. MOVEMENT DISORDERS CLINICAL PRACTICE. 2021.10.1002/MDC3.13233. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN, UBD: , UDI#:. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    EVIDENTE VGH, ROKHLIN P, EVIDENTE MH, LAMBERT M, GARRETT R, PONCE FA. THALAMIC DEEP BRAIN STIMULATION IS EFFECTIVE IN ALLEVIATING CR ANIOCERVICAL DYSTONIA. MOVEMENT DISORDERS CLINICAL PRACTICE. 2021.10.1002/MDC3.13233. SUMMARY: MEIGE SYNDROME (MS) IS AN IDIOPATHIC ADULT-ONSET SEGMENTAL DYSTONIA CHARACTERIZED INITIALLY BY BLEPHAROSPASM, FOLLOWED BY DYSTONIA OF THE MID-FACIAL AND LOWER FACIAL MUSCLES, MOUTH, JAW, TONGUE, OR PHARYNGEAL MUSCLES. 1¿3 PATIENTS WITH MS MAY HAVE FURTHER SPREAD OF DYSTONIA TO THE CERVICAL MUSCLES, LEADING TO CRANIOCERVICAL DYSTONIA (CD). SEVERE MEIGE OR CD IS OFTEN REFRACTORY TO ORAL MEDICATIONS. BOTULINUM TOXIN (BTX) INJECTIONS REMAIN THE CORNERSTONE OF THE MANAGEMENT OF MS OR CD, ALTHOUGH MANY PATIENTS EXPERIENCE A DIMINISHED RESPONSE OVER TIME ATTRIBUTED TO EITHER PROGRESSION OF THE DISEASE OR DEVELOPMENT OF NEUTRALIZING ANTIBODIES. 2,3 WE AND OTHER GROUPS HAVE REPORTED THE EFFECTIVENESS OF DEEP BRAIN STIMULATION (DBS) OF EITHER THE GLOBUS PALLIDUS INTERNUS OR SUBTHALAMIC NUCLEUS FOR MEDICALLY REFRACTORY MS OR CD. 4¿7 WE REPORT ON A PATIENT WITH MEDICALLY REFRACTORY CD WHO UNDERWENT BILATERAL ASLEEP DBS SURGERY OF THE VENTRALIS INTERMEDIUS NUCLEUS (VIM) WITH DRAMATIC RESPONSE. REPORTED EVENTS: A (B)(6)-YEAR-OLD FEMALE PATIENT WITH DYSTONIA WAS IMPLANTED WITH A LEAD THAT SHOWED A STEREOTACTIC RADIAL ERROR OF 1.1 MM POSTEROMEDIAL ON THE LEFT AND 0.8 MM POSTEROMEDIAL ON THE RIGHT. THE LEFT VIM ELECTRODE SETTINGS WERE CASE (+), 0, 0.7V, 60 MICROSECONDS, AND 185 HZ, THE RIGHT VIM ELECTRODE SETTINGS WERE 11 (+), 8, 0.7V, 60 MICROSECONDS, AND 185 HZ. AT THESE SETTINGS, THE PATIENT HAD IMMEDIATE IMPROVEMENT OF THEIR HAND TREMORS, BUT ONLY MILD IMPROVEMENT OF THEIR FACIAL DYSKINESIAS AND NECK MOVEMENTS. THE AMPLITUDE WAS INCREASED 3 DAYS LATER TO 1.5 VOLTS IN EACH SIDE, AND THEIR EYELID SPASMS, FACIAL DYSKINESIAS, AND RETROCOLLIS WERE MARKEDLY IMPROVED. THE PATIENT DID NOTE THEY HAVE TRANSIENT PARESTHESIA IN THEIR HANDS OR PERIORAL REGION WITH PROGRAMMING ADJUSTMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232337 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M MRU MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR