BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOTED ATTACHMENT B1

    MDR report key: 534701 · Received January 8, 2004

    Report

    Report Number
    1625507-2004-00003
    Event Type
    Malfunction
    Date Received
    January 8, 2004
    Date of Event
    November 13, 2003
    Report Date
    December 9, 2003
    Manufacturer
    MEDTRONIC MIDAS REX
    Product Code
    HBE
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    "WHILE TURNING A FLAP, THE DRILL CAME APART. ALL MIDAS REX EQUIPMENT HAD BEEN PULLED FROM THE HOSPITAL." VOLUNTARY MEDWATCH REPORT REC'D FROM MEDICAL FACILITY INDICATED PT WAS UNDERGOING A LEFT ANTERIOR TEMPORAL LOBECTOMY DUE TO INTRACTABLE SEIZURES (EPILEPSY) WHEN THE MIDAS DRILL BIT ADVANCED PAST THE DRILL GUIDE. THIS CAUSED THE DRILL BIT TO CUT INTO THE DURA MEMBRANE THAT MIGHT CAUSE SWELLING AND AFFECT THE PT'S FUNCTIONS. "THE EQUIPMENT INVOLVED WAS FORWARDED BY THE MEDICAL FACILITY TO AN INDEPENDENT LAB FOR EVALUATION. RESULTS OF THIS ANALYSIS WERE NOT AVAILABLE. NO DETAILS REGARDING EQUIPMENT IDENTIFICATION NUMBER COULD BE OBTAINED. ALTHOUGH IT WAS REPORTED THE EVENT WOULD INCREASE THE LENGTH OF THE HOSPITAL STAY, AND MAY REQUIRE REHAB, NO SPECIFIC PT IMPACT INFO COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOOTED ATTACHMENT B1 PNEUMATIC SURGICAL DRILL ATTACHMENT HBE MEDTRONIC MIDAS REX NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention