BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3153308 · Received June 8, 2013

    Report

    Report Number
    1723170-2013-00411
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT PROVIDED AS SITE REPRESENTATIVE, (B)(6), DECLINED, QUOTING THE GOVERNING RESTRICTIONS. A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED PROVIDING TECHNIQUE INSTRUCTION TO THE SURGEON. ALSO REPORTED THE SYSTEM WAS WORKING PROPERLY. NO PARTS/DEVICES HAVE BEEN RETURNED TO MANUFACTURER FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 1

    PER MEDTRONIC REPRESENTATIVE'S INVESTIGATION THE SITE IS USING SCANS THAT ARE NOT TO MEDTRONIC NAVIGATION PROTOCOL. ALLEGED INACCURACY LIKELY CAUSED BY SCAN SLICING AND THICKNESS NOT AT 1 TO 1 RATIO. UPON COMPLETION OF THE SOFTWARE INVESTIGATION, NO SOFTWARE FAULTS OR ANOMALIES WERE FOUND TO BE THE CAUSE OF THE ALLEGED INACCURACY.

    Additional Manufacturer Narrative · 1

    PATIENT ID, AGE AND SEX PROVIDED. WEIGHT WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    A SURGEON ALLEGED AN INACCURACY THAT OCCURED WHILE IN AN ENT PROCEDURE, NO SPECIFIC MEASUREMENT WAS PROVIDED. THE SURGEON OPTED TO COMPLETE THE SURGERY WITHOUT THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255973 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR