BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2362995 · Received December 2, 2011

    Report

    Report Number
    3007566237-2011-09168
    Event Type
    Injury
    Date Received
    December 2, 2011
    Report Date
    November 4, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: ARLE, J. E., ZANI, J., SHILS, J. L. INTRAOPERATIVE DECISION MAKING WITH MER FOR STN DBS IN PD AND THE POTENTIAL RELATIONSHIP TO PT SELECTION. THE OPEN NEUROSURGERY JOURNAL 2011; 4: 36-41. SUMMARY: THE AUTHORS REPORT ON INTRAOPERATIVE MER FOR PLACEMENT OF THE DBS LEAD IN THE STN, THE VARIABLES CONTRIBUTING TO DECISION MAKING DURING MER, AND HOW THE OVERALL OUTCOME IN TERMS OF UNWANTED SIDE EFFECTS IS RELATED TO THE DECISION MAKING DURING SURGERY. REPORTABLE EVENT: THERE WERE FOUR ASYMPTOMATIC HEMORRHAGES (<2CM) OBSERVED. ADDITIONAL INFO REGARDING INTERVENTIONS AND OUTCOMES HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA MHY - STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN MHY MEDTRONIC NEUROMODULATION 3387 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention