BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 1901983 · Received November 12, 2010

    Report

    Report Number
    9614453-2010-09400
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION REPORTING, THE INS DISPLAYED A POWER ON RESET MODE. LATER, IT REACHED BATTERY DEPLETION MUCH EARLIER THAN EXPECTED. STIMULATION PARAMETERS:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC EUROPE SARL 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention