BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 513065 · Received February 25, 2004

    Report

    Report Number
    2029203-2004-00045
    Event Type
    Injury
    Date Received
    February 25, 2004
    Date of Event
    January 1, 2004
    Report Date
    February 25, 2004
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 12/2003, THE PT REPORTEDLY DEVELOPED A SEROMA AT THE IMPLANT SITE WHEN EXTERNAL HEADPIECE WAS PLACED. THE PT DISCONTINUED USE OF THE EXTERNAL HEADPIECE FOR SOME TIME AND SEROMA WAS RESOLVED WITHOUT MEDICAL INTERVENTION. WHEN EXTERNAL HEADPIECE WAS AGAIN PLACED ON THE PT, SEROMA RETURNED. ALLERGIC REACTION HAS BEEN RULED OUT BY THE SURGEON. IN 01/2004, THE SURGEON REPORTEDLY LANCED THE SEROMA AND RECOMMENDED THAT THE PT DISCONTINUE USE OF EXTERNAL HEADPIECE FOR SEVERAL MONTHS.

    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 19 MO Required Intervention