BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 3012460 · Received March 15, 2013

    Report

    Report Number
    3006556115-2013-00088
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 23, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT'S ELECTRODE ARRAY WAS FOLDED ON ITSELF IN THE PT'S COCHLEA. THE SURGEON REPORTED THAT THE INSERTION OF THE ELECTRODE WAS DIFFICULT DURING THE INITIAL SURGERY. THE PT'S DEVICE WAS EXPLANTED AND THE PT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110546 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1500-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention