BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 1980414 · Received February 3, 2011

    Report

    Report Number
    1723170-2011-00072
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    December 24, 2010
    Report Date
    January 4, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ID AND WEIGHT WERE NOT AVAILABLE. DEVICE INFORMATION WAS NOT AVAILABLE. DEVICE MANUFACTURE DATE WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. THE INITIAL REPORTER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION TO ALLOW FOR INVESTIGATION OR FOLLOW-UP.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED TO MEDTRONIC THAT HE RECEIVED INFORMATION ON (B)(6)2011 FROM A PHYSICIAN REGARDING A POSSIBLE ADVERSE EVENT IN WHICH A MEDTRONIC NAVIGATION DEVICE PURPORTEDLY "FELL" DURING A PROCEDURE AND PURPORTEDLY "BLINDED" A PATIENT "IN ONE EYE." THE PHYSICIAN WHO REPORTED THE POSSIBLE ADVERSE EVENT TO THE MEDTRONIC REPRESENTATIVE STATED THAT THE CASE "HAPPENED SOMEWHERE IN THE MIDWEST ON CHRISTMAS EVE," BUT DID NOT PROVIDE ANY FURTHER DETAILS REGARDING THE POSSIBLE ADVERSE EVENT. ADDITIONAL REQUESTS FROM MEDTRONIC TO PROVIDE FURTHER SPECIFIC INFORMATION, INCLUDING EXACTLY WHERE THE POSSIBLE EVENT MAY HAVE OCCURRED, WHAT MAY HAVE CAUSED THE MEDTRONIC NAVIGATION DEVICE TO PURPORTEDLY FALL DURING THE PROCEDURE, THE IDENTITY OF THE ATTENDING PHYSICIAN, ETC HAVE GONE UNANSWERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN UNKNOWN NAVIGATION SYSTEM HAW MEDTRONIC NAVIGATION, INC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention| S