BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENS

    MDR report key: 1213289 · Received October 27, 2008

    Report

    Report Number
    2182207-2008-06902
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    April 1, 2007
    Report Date
    September 28, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A FRONTAL LOBE, AND BRAIN STEM BLEED AT INITIAL PHASE OF IMPLANT. THE PT WAS UNABLE TO SIT UP AFTERWARD. THE PT WAS ADMITTED TO A REHABILITATION HOSPITAL FOR CONTINUED CARE. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED, IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENS MHY MEDTRONIC NEUROMODULATION ENS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R LEAD MODEL 3387S LOT#V023028| EXPLANTED| IMPLANTED| EXPLANTED| IMPLANTED| LEAD MODEL 3387S LOT#V023028