BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDAS REX PNEUMATIC MOTOR

    MDR report key: 1852328 · Received September 29, 2010

    Report

    Report Number
    1625507-2010-00056
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    January 1, 2000
    Report Date
    August 31, 2010
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K953434
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS THE DEVICE WAS NOT RETURNED AND THERE IS NO SERIAL NUMBER INFORMATION AVAILABLE. EVENT DATE IS ESTIMATED BASED ON ARTICLE INDICATING THAT EVENT OCCURRED IN 2000.

    Description of Event or Problem · 1

    SUDDEN HEARING LOSS FOLLOWING THE USE OF A MIDAS REX MOTOR FOR A CRANIOTOMY WAS REPORTED IN JOURNAL OF CLINICAL NEUROSCIENCE 17 (2010) 149-152 ARTICLE "SUDDEN HEARING LOSS FOLLOWING NON-PETROUS CRANIOTOMY" AUTHORED BY J.C. RYAN, P.A. BIRD, AND J.A. BONKOWSKI. A (B)(6) WOMAN WITH PAST HISTORY OF BILATERAL OTOSCLEROSIS AND TOTAL HEARING LOSS ON RIGHT AND LOW TONE ISLAND OF HEARING ON LEFT UNDERWENT A CRANIOTOMY TO REMOVE A RIGHT SUBOCCIPITAL PETROUSMENINGIOMA. IMMEDIATELY FOLLOWING THE PROCEDURE, THE PATIENT REPORTED LOSS OF RESIDUAL HEARING. TESTING CONFIRMED THERE WAS NO LONGER ANY MEASURABLE HEARING. PATIENT WAS TREATED BY COCHLEAR IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDAS REX PNEUMATIC MOTOR HBB- MOTOR, DRILL, PNEUMATIC HBB MEDTRONIC POWERED SURGICAL SOLUTIONS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other