BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2090829 · Received May 10, 2011

    Report

    Report Number
    3006556115-2011-00223
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SURGERY ON (B)(6), 2011 TO REPLACE THE MIGRATED MAGNET OF THE INTERNAL DEVICE. AFTER SURGERY, IMPEDANCES WERE WITHIN NORMAL LIMITS. THE PATIENT IS SCHEDULED FOR DEVICE REACTIVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 MO Required Intervention