BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2825356 · Received November 8, 2012

    Report

    Report Number
    3007566237-2012-02665
    Event Type
    Injury
    Date Received
    November 8, 2012
    Date of Event
    November 26, 2011
    Report Date
    October 12, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, NEU_UNKNOWN_EXT LOT# SERIAL# UNKNOWN, PRODUCT TYPE EXTENSION PRODUCT ID, 3389 LOT# SERIAL# UNK, PRODUCT TYPE LEAD. (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    SPAGNOLO, F., PICOZZI, P., FRANZIN, A., MARTINELLI, V., COMI, G., VOLONTE, M. A. PAINFUL CERVICAL DYSTONIA TRIGGERED BY THE EXTENSION WIRE OF A DEEP BRAIN STIMULATOR. JOURNAL OF CLINICAL NEUROSCIENCE : OFFICIAL JOURNAL OF THE NEUROSURGICAL SOCIETY OF AUSTRALASIA. 2012;19(11):1582-1583. DOI: 10.1016/J.JOCN.2011.11.040. SUMMARY: DEEP BRAIN STIMULATION (DBS) CAN BE COMPLICATED BY ADVERSE EVENTS, WHICH ARE GENERALLY CLASSIFIED AS SURGICAL-HARDWARE OR STIMULATION-RELATED. HERE WE REPORT THE ONSET OF A PAINFUL CERVICAL DYSTONIA PROBABLY TRIGGERED BY THE EXTENSION WIRE OF A SUBTHALAMIC NUCLEUS (STN)-DBS DEVICE IN A WOMAN SUFFERING FROM ADVANCED PARKINSON'S DISEASE (PD). TWO MONTHS AFTER IMPLANTATION OF THE STN-DBS DEVICE, OUR PATIENT DEVELOPED A PAINFUL CERVICAL DYSTONIA, WHICH WAS NOT RESPONSIVE TO NEUROSTIMULATION OR TO MEDICATION. NO SIGN OF INFECTIONS OR FIBROSIS WAS DETECTED. A PATCH TEST WITH THE COMPONENTS OF THE DEVICE WAS PERFORMED, REVEALING NO HYPERSENSIBILITY. THE PATIENT WAS REFERRED BACK TO SURGERY TO REPOSITION THE PULSE GENERATOR IN THE CONTRALATERAL SUBCLAVIAN REGION. A DEEPER CHANNELING OF THE WIRE EXTENSIONS PRODUCED A COMPLETE REMISSION OF THE PAINFUL DYSTONIA. REPORTED EVENT: A (B)(6) WOMAN EXPERIENCED A TENSOR SENSATION ALONG THE EXTENSION WIRES ACCOMPANIED BY MANY DAILY EPISODES OF INTENSE, PAINFUL SPASMS WITH ABNORMAL POSTURE INVOLVING THE NECK AND RIGHT SHOULDER. THE SYMPTOMS DID NOT CHANGE WHEN STIMULATION WAS TURNED OFF. THE PATIENT UNDERWENT SURGERY TO REPOSITION THE IMPLANTABLE NEUROSTIMULATOR (INS) IN THE CONTRALATERAL SUBCLAVIAN REGION AND A DEEPER CHANNELING OF THE WIRE EXTENSION WAS PERFORMED. COMPLETE REMISSION OF THE PAINFUL DYSTONIA WAS ACHIEVED FOR THE 2.5 YEARS SINCE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention