BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 3871177 · Received May 29, 2014

    Report

    Report Number
    3871177
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 9, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A HIRES 90K ADVANTAGE COCHLEAR IMPLANT DEVICE WITH A HIFOCUS MID-SCALA ELECTRODE, WAS INITIALLY PLACED IN THE POCKET. THIS WAS LOADED ON THE INSERTION TOOL. AFTER THE INSERTION TOOL WAS DISCHARGED, IT WAS NOTICED THAT THE STYLET WAS NOT REMOVE BY THE INSERTION TOOL AS IT SHOULD. THE ELECTRODE WAS THEN WITHDRAWN AND INSPECTED UNDER THE MICROSCOPE, AND THERE WAS A POSSIBILITY OF A BREACH OF THE DISTAL TIP WHERE THE STYLET MAY HAVE PIERCED IT. THAT DEVICE WAS REMOVED FROM THE POCKET AND REMOVED AND RETURNED TO THE COMPANY, AND WE ELECTED TO PROCEED WITH THE BACKUP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317305 HIRES 90K IMPLANT, COCHLEAR MCM ADVANCED BIONICS CORPORATION CI-1500-04 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR