BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2243501 · Received August 31, 2011

    Report

    Report Number
    3006556115-2011-00438
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY EXPERIENCING PAIN, REDNESS, SWELLING, AND SCABBING AT THE IMPLANT SITE SINCE FALLING DOWN THE STAIRS AND HITTING THE MAGNET SITE. THE PT WAS ALSO EXPERIENCING INTERMITTENCIES. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. TESTING SHOWED THAT THE DEVICE IS FUNCTIONING. THE PT WAS RECOMMENDED TO DISCONTINUE WEARING THE EXTERNAL EQUIPMENT AND USE NEOSPORIN DAILY. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention