BEUDAMED
    FDA Adverse Event Death Summary report: N

    IPC® STYLUS TRANSNASAL BUR

    MDR report key: 4484665 · Received February 4, 2015

    Report

    Report Number
    1045254-2015-00027
    Event Type
    Death
    Date Received
    February 4, 2015
    Report Date
    January 8, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    PMA / PMN Number
    K081277
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO A SYSTEM ISSUE, UNABLE TO SELECT ¿DEATH¿ AS THE OUTCOME ATTRIBUTED TO ADVERSE EVENT BECAUSE THE ¿DATE OF DEATH¿ IS UNKNOWN. ATTEMPTS TO OBTAIN DETAILED INFORMATION REGARDING PATIENT AND EVENT WERE UNSUCCESSFUL. (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: (1) LEGEND EHS STYLUS MOTOR (EM200); SN: UNKNOWN; MANUFACTURED: UNKNOWN; DEVICE NOT RETURNED TO MEDTRONIC; 510K: K012453 (B)(4) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 4MM TRANSNASAL BUR WAS USED IN AN ANTERIOR SKULL BASE CASE WHERE THE PATIENT¿S CAROTID ARTERY WAS DAMAGED, RESULTING IN AN EMERGENCY SITUATION IN THE ¿THEATRE.¿ ALTHOUGH THE PATIENT WAS STABILIZED PRIOR TO BEING TRANSFERRED TO THE ¿WARD¿, UNFORTUNATELY THE PATIENT DIED DUE TO THE DAMAGE SUSTAINED TO THEIR CAROTID ARTERY. THIS IS THE ONLY INFORMATION PROVIDED¿HOWEVER, THE SURGEON WAS CONFIDENT THAT THE EVENT WAS NOT THE FAULT OF THE TRANSNASAL BUR. THERE IS CURRENTLY AN INTERNAL INVESTIGATION AT THE HOSPITAL TO ESTABLISH THE FACTS OF WHAT HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81486 IPC® STYLUS TRANSNASAL BUR DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. TN40RCD NI

    Patients

    Seq Age Sex Outcome Treatment
    1