BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1083074 · Received March 12, 2008

    Report

    Report Number
    3006556115-2008-00112
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTRODE HAD MIGRATED OUT OF THE COCHLEA. THE SURGEON ATTEMPTED TO REINSERT THE ELECTRODE ARRAY, BUT HAD DIFFICULTY REINSERTING THE ARRAY DURING SURGERY. THE PATIENT WAS RE-IMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-01

    Patients

    Seq Age Sex Outcome Treatment
    1