BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 527872 · Received June 3, 2004

    Report

    Report Number
    2029203-2004-00120
    Event Type
    Injury
    Date Received
    June 3, 2004
    Date of Event
    May 5, 2004
    Report Date
    June 3, 2004
    Manufacturer
    ADVANCED BIONICS CORP
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IN 12/2003, THE PT REPORTEDLY EXPERIENCED A PROBLEM WITH EXTERNAL HEADPIECE RETENTION. THE PT CONTINUED TO BE MONITORED BY THE CENTER. IN 2004, THE CO WAS NOTIFIED THAT THE SURGEON SCHEDULED SKIN FLAP REVISION SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention