BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2474763 · Received March 1, 2012

    Report

    Report Number
    3007566237-2012-00439
    Event Type
    Injury
    Date Received
    March 1, 2012
    Date of Event
    September 2, 2011
    Report Date
    February 16, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: KAHN, ELYNE, PIERRE-FRANCOIS D'HAESE, BENOIT DAWANT, LAURA ALLEN, CHRIS KAO, P. DAVID CHARLES, AND PETER KONRAD. "DEEP BRAIN STIMULATION IN EARLY STAGE PARKINSON'S DISEASE: OPERATIVE EXPERIENCE FROM A PROSPECTIVE RANDOMISED CLINICAL TRIAL." JOURNAL OF NEUROLOGY, NEUROSURGERY AND PSYCHIATRY 83.2 (2011): 164-70. SUMMARY: RECENT EVIDENCE SUGGESTS THAT DEEP BRAIN STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN-DBS) MAY HAVE A DISEASE MODIFYING EFFECT IN EARLY PARKINSON'S DISEASE (PD). A RANDOMIZED, PROSPECTIVE STUDY IS UNDERWAY TO DETERMINE WHETHER STN-DBS IN EARLY PD IS SAFE AND TOLERABLE. THE AUTHORS PRESENT 15 PD PATIENTS WHO WERE TREATED WITH STN-DBS IN THE EARLY STAGES OF THE DISEASE. THE PERIOPERATIVE ADVERSE EVENTS IN THIS TRIAL OF SUBJECTS WITH EARLY STAGE PD ARE COMPARABLE WITH THOSE REPORTED FOR STN-DBS IN ADVANCED PD. REPORTED EVENT: ONE PATIENT EXPERIENCED MILD, NON-HEMORRHAGIC STROKE (SPECIFICALLY BASAL GANGLIA INFARCT) RESULTING IN MILD COGNITIVE CHANGES AND MILD RIGHT UPPER EXTREMITY PARESIS. THIS PATIENT HAD MILD CONTRALATERAL FACIAL AND UPPER EXTREMITY WEAKNESS THAT WAS PRESENT AT THE 2 YEAR POST-SURGERY FOLLOW-UP. ONE PATIENT EXPERIENCED TRANSIENT PERI-OPERATIVE HALLUCINATIONS. FURTHER INFORMATION IS BEING REQUESTED; A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION. 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S LEAD MODEL 3389 LOT# UNK SERIAL# UNK IMPLANTED: