BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 507472 · Received January 21, 2004

    Report

    Report Number
    2029203-2003-00262
    Event Type
    Injury
    Date Received
    January 21, 2004
    Date of Event
    December 29, 2003
    Report Date
    January 21, 2004
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S WOUND REPORTEDLY WAS NOT HEALING AFTER 12/2003 COCHLEAR IMPLANT SURGERY. THE PT WAS SEEN AT THE CENTER. IN 01/2004 (EXACT DATE NOT GIVEN) DUE TO DEHISCENCE OF THE SKIN FLAP, THE SURGEON PERFORMED REVISION SURGERY. PERMANENT SUTURES WERE PLACED ALONG THE LENGTH OF THE POST-AURICULAR CREASE. THE PATIENT'S DEVICE REMAINS IMPLANTED.

    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 3 YR Required Intervention